Radiation therapy

Displaying 220 studies

  • Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer Rochester, MN

    The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

  • Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN; La Crosse, WI

    This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink ...

  • 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis Rochester, MN

    This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.

  • A Study of Whole-Brain Radiation Therapy with or without Avoiding the Hippocampus while Treating Patients with Limited or Extensive Stage Small Cell Lung Cancer La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN

    This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the ...

  • A Study to Review Patient Experiences and Obtain Follow Up from Patients having Skin Directed Radiation Therapy for Cutaneous Inflammatory Dermatoses Rochester, MN

    The purpose of this study is to:

    1. To determine the response rates and toxicity in patients that have undergone skin directed radiation therapy for inflammatory cutaneous dermatoses.
    2. To review and report the institutional experience, clinical responses, and recurrence rates after skin directed radiation therapy by varying dosing regimens and treatment regimens.
    3. To gather information on technical innovations used in the treatment of inflammatory dermatoses with the goal of publishing our findings so that others can utilize techniques we have found to be useful in the treatment of particularly challenging cases.

  • A Study to Evaluate Heart Failure Biomarker to Predict Cardiomyopathy After Acute Radiation Jacksonville, FL

    The purpose of this study are to evaluate whether serum sST2 levels increase after RT compared to troponin (as a control), and to correlate serum sST2 and troponin levels at completion of RT with cardiac radiation dosimetry.

     

  • A Study of the Effectiveness of Sulfasalazine in Preventing Acute Diarrhea in Patients with Cancer who are Undergoing Pelvic Radiation Therapy Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study of sulfasalazine is to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy. Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

  • A Registry Study for the Long-Term Outcomes of Radiation Therapy Scottsdale/Phoenix, AZ

    The purpose of this long term registry study is to collect and analyze information from patients being treated with various forms of radiation therapy to improve the treatment of future patients.

  • Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary Rochester, MN

    Single-arm phase 2 study to examine pembrolizumab and concurrent radiation to induce an abscopal effect in patients with previously treated carcinoma of unknown primary (CUP16-268)

  • Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients with Brain Metastases that have been Removed by Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

    PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

  • Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer Scottsdale/Phoenix, AZ

    The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

  • Stereotactic Radiation Therapy for Pediatric Sarcomas Rochester, MN

    The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the adult population. However, SBRT (stereotactic body radiation therapy) has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a ...

  • A Clinical Use Application for the Humanitarian Use Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia Eau Claire, WI

    This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.

  • Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy Rochester, MN

    Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, confromal radiation doses (>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the ...

  • Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study Albert Lea, MN; Scottsdale/Phoenix, AZ; Rochester, MN

    To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with radiation therapy.

  • Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.

  • A Registry of Patient Data and DNA Samples for Early Detection of Radiation Related Side Effects Jacksonville, FL

    The purpose of this study is to help predict which patients are at greater risk for side effects from radiotherapy.

    Aims, purpose, or objectives:

    1. Establish a prospective cohort of 500 patients with breast, lung, and prostate cancer treated with external beam radiotherapy at Mayo Clinic Florida followed with standardized quality of life and toxicity assessments.
    2. Establish a registry of patient data and germline DNA samples for validation of models and biomarkers for early detection of risk of radiotherapy related side effects.
    3. The registry will establish a cohort of patients at May Clinic Florida that ...

  • A Study to Measure the Impact of Continuous Positive Airway Pressure for Reducing Breathing Motion Rochester, MN

    The purpose of this study is to measure the extent that breathing motion is reduced in healthy volunteers after continuous positive airway pressure (CPAP) used. If CPAP administration will significantly reduce breathing motion, this may help cancer patients who are undergoing proton radiotherapy, so they may not have to hold their breath during the procedure.

  • Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients with Early Stage Non-Small Lung Cancer (NSCLC) Rochester, MN

    This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.

  • Gene Therapy and Radioactive Iodine in Treating Patients with Locally Recurrent Prostate Cancer that Did Not Respond to External-Beam Radiation Therapy Rochester, MN

    RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.

    PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.

  • A Study of Proton Radiation Divided into Fewer Doses for Low Risk Prostate Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

  • Genomic Assessment of Patients With Severe Radiation Reactions Rochester, MN

    Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.

  • Radiation Therapy with or without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Jacksonville, FL; Rochester, MN; La Crosse, WI; Albert Lea, MN; Mankato, MN

    RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together ...

  • Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation ...

  • A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors Rochester, MN; Jacksonville, FL

    The purpose of this research is to study radiographic control at the 3 month time-point, the side effects (good & bad), survival outcomes and proof of this idea in patients who have had grid therapy for locally advanced bulky tumors of the heat and neck, thorax, abdomen and extremities.

  • Proton-Based Stereotactic Ablative Body Radiotherapy for Prostate Cancer Rochester, MN

    Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.

    Patients undergo evaluation and medical care in the same way that they would if they were not part of this trial. This may include standard of ...

  • A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma No Locations

    The purpose of this study is to tailor treatment for medulloblastoma based on molecular distinctions between tumors in order to improve cure rates for molecularly aggressive medulloblastoma, while reducing treatment-related morbidities in survivors of less aggressive medulloblastoma. It is possible that subjects in this study will benefit from a reduction in treatment complications, more effective therapy, and higher rates of survival.

  • Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers Rochester, MN; Jacksonville, FL

    This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential ...

  • Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin Scottsdale/Phoenix, AZ

    This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.

  • Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer Rochester, MN

    The purpose of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

  • A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1 Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.

  • Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Jacksonville, FL; Rochester, MN

    Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

  • Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Rochester, MN

    This phase I trial studies the side effects and the best dose of trametinib when given together with combination chemotherapy and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to ...

  • A Study of Response Rate and Survival from Combined Chemotherapy, Surgery and Radiation Therapy for Patients with Malignant Mesothelioma Rochester, MN

    The purpose of this study is to follow patients with malignant mesothelioma of the lung after they have had combined chemotherapy, surgery, and intensity modified radiation therapy and determine response rates and overall survival.

  • A Study to Evaluate Brigatinib Before Brain Irradiation Rochester, MN

    The purpose of this study is to evaluate brigatinib alone for patients with brain metastases from anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), who have either not been treated previously with a tyrosine kinase inhibitor (TKI) targeting ALK or who have had prior exposure to crizotinib.

  • A Study of Four-Dimensional MRI for Image-Guided Radiation Therapy Scottsdale/Phoenix, AZ

    The purpose of this study is to develop and evaluate four-dimensional Magnetic Resonance Image (4DMRI) sequence to accurately map tumor motion for radiation treatment.

  • Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck Rochester, MN; Scottsdale/Phoenix, AZ

    The overall goal of this trial is to identify a less toxic approach to the delivery of conformal radiation therapy for patients with cancers of the oropharynx.

  • Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery Scottsdale/Phoenix, AZ; Rochester, MN; Scottsdale/Phoenix, AZ; Rochester, MN

    The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...

  • Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy Rochester, MN

    The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.

  • A Study to Evaluate Contouring Organs at Risk for Treatment Planning Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine:  if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing.  These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow. 

    Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations ...

  • A Study to Evaluate Artificial Intelligence-driven Assistance for Treatment Planning in Radiation Oncology Rochester, MN

    The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.

     

     

  • Radiation Therapy with or without Temozolomide in Treating Patients with Anaplastic Glioma Jacksonville, FL; Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

    PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy ...

  • A Study of the Performance of Genome Sequencing as a Clinical Test to Identify Multifocal Lung Cancers for Treatment, versus Advanced Metastatic Disease Rochester, MN

    The purpose of this study is to assess the use and performance of a genome sequencing test to identify multifocal lung cancer tumors, which can be treated with surgery or radiation, and advanced stage metastatic lung cancer, which has the option of palliative or supportive care.

  • Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.

  • Intensity-Modulated Radiation Therapy and Paclitaxel with or without Pazopanib Hydrochloride in Treating Patients with Anaplastic Thyroid Cancer Jacksonville, FL; Rochester, MN

    This randomized phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy (IMRT) and paclitaxel together with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking ...

  • A Study of Performing Surgery for Resectable Malignant Pleural Mesothelioma After Radiation Therapy Rochester, MN

    The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.  

  • Evaluating Highly Flexible (aka AIR) RF Coils for Patients Undergoing MR Imaging for Radiation Therapy Planning Rochester, MN

    To assess the quality of images obtained with a new RF (AIR) coil when compared to those obtained using FDA approved RF coils of patients undergoing MR imaging for radiation therapy treatment planning.

  • Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery Rochester, MN

    This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

  • TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill ...

  • A Study of Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer La Crosse, WI; Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to evaouate how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.

  • Short-course Radiation Therapy for Hepatocellular Carcinoma Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).

  • Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies Rochester, MN

    This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.

  • MDM2 Inhibitor AMG-232 and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

  • A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy Scottsdale/Phoenix, AZ

    The purpose of this study is to measure how patient anxiety changes using a validated patient reported outcome measure, to measure radiotherapy completion rates in the American Indian/Alaska Native (AI/AN) community, and to measure patient perception of information received using a validated patient reported outcome measure.

     

     

  • Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer Albert Lea, MN

    The purpose of this study is to determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation therapy (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

     

  • Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Jacksonville, FL; Rochester, MN

    This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

  • Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery Mankato, MN

    The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...

  • A Study to Find the Recommended Dose for Further Research for VX-970 and Whole Brain Radiation Therapy to Treat Patients with Brain Metastases from Non-Small Cell Lung Cancer Jacksonville, FL; Rochester, MN

    The purpose of this study is to assess the side effects and best dose of ATR kinase inhibitor VX-970 when given together with whole brain radiation therapy for the treatment of patients who have non-small cell lung cancer that has spread from the original (primary) tumor to the brain.  VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving VX-970 together with radiation therapy may be a better treatment for non-small cell lung cancer.

  • A Study to Evaluate the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors Rochester, MN

    The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.

  • A Study to Investigate the Effects of GC4419 on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer Jacksonville, FL

    The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

  • Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma Rochester, MN

    This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if ...

  • A Study of Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients with Pancreatic Cancer with Vascular Involvement Rochester, MN; Jacksonville, FL

    The purpose of this study is to to evaluate the rate of overall survival (OS) at two years in patients with either borderline or locally advanced pancreatic cancer who receive electron beam intraoperative radiation therapy (IORT) following chemotherapy and radiation therapy.

  • Vorinostat, Temozolomide, or Bevacizumab in Combination with Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients with Newly Diagnosed High-Grade Glioma Rochester, MN

    This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. ...

  • Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery Rochester, MN

    This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell ...

  • Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA Rochester, MN

    There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses ...

  • Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to test the safety of radiation therapy given at increased doses in a shorter period of time in order to find out what effects, good and/or bad, it has on the patient and the lung cancer. The standard way of giving the radiation therapy is to give it once daily for 6 to 7 weeks. The study is currently testing if a higher amount of radiation therapy per treatment can be given as well as shorten the total number of treatments to 4 or 5 weeks. The goal is that a higher dose of ...

  • Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients with Pancreatic Cancer That Has Been Removed by Surgery Jacksonville, FL; Rochester, MN

    This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor ...

  • 3D Surface Scanning Scottsdale/Phoenix, AZ

    The purpose of this study is to examine the potential for using a 3D scan of a patient’s treatment surface as a surrogate for a conventional CT simulation in electron radiation therapy.

     

  • Radiation Therapy in Treating Patients with Extensive Stage Small Cell Lung Cancer Scottsdale/Phoenix, AZ

    RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.

    PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

  • Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma Rochester, MN

    The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.

  • Study to Evaluate the Efficacy and Safety of Lutathera in Patients with Grade 2 and Grade 3 Advanced GEP-NET Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.

  • Evaluating Patient Reported Outcomes in Radiation Therapy, The PRO-RT Study Rochester, MN

    The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo device enabled patient specific data aggregation, will increase the completeness and accuracy of the Outcomes Registry and improve patient engagement with the care teams, post radiation, by acquiring linked outside EHR information facilitating improved collection of patient reported outcome surveys, and biometric data via a wearable device.

    With a rise in health care costs, there is an urgent need to evaluate patient outcomes and the value of care levering real patient, big data from the ...

  • A Study Using Chemotherapy Followed by Radiation Therapy in Treating Younger Patients with Newly Diagnosed Localized Central Nervous System Germ Cell Tumors Rochester, MN

    Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.

  • Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Ependymoma Rochester, MN

    This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to ...

  • Semen Analysis in Chemotherapy Rochester, MN

    The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.

  • Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations Rochester, MN

    The purpose of this study is to evaluate how well veliparib, radiation therapy, and temozolomide work in treating participants with newly diagnosed malignant glioma without H3 K27M or BRAFV600E mutations. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide ...

  • Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck Rochester, MN

    This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can ...

  • A Single Patient Study of Severe Fibrosis after Breast Radiation Rochester, MN

    This study is being performed to better understand the mechanisms behind severe radiation toxicity of a patient with severe fibrosis after breast radiation. 

  • Assessment of Predicted LET and Dosimetry in Relation to Treatment-Related Injury Following Proton Therapy for Primary Pediatric Central Nervous System, Base of Skull, and Malignancies Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate LET-based modeling as an early and accurate predictor for white-matter changes as identified on MRI and DTI in pediatric patients with primary central nervous system and skull base malignancies following proton beam therapy

  • A Study to Evaluate Carbon Therapy vs. Proton Therapy for Pelvic Sarcomas Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this comparative effectiveness study is to evaluate functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.

     

  • A Study to Determine the Best Individualized Cancer Therapy Using Circulating Tumor DNA (ctDNA) in Patients with GI, CNS, and Thoracic Cancers. Jacksonville, FL

    This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.

  • Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma Rochester, MN

    This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as ...

  • A Study to Evaluate Regional Radiotherapy in Biomarker Low-Risk Node Positive Breast Cancer Jacksonville, FL

    The purpose of this study is to compare the effects on low-risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

  • Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma Rochester, MN

    This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

  • A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas Rochester, MN

    For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most ...

  • Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Rochester, MN

    For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The ...

  • Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

  • A Study to Evaluate CB-839 With Radiation Therapy and Temozolomide in Treating Participants With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the side effects and best dose of  CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with ...

  • Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone Rochester, MN

    This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for ...

  • Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer Rochester, MN

    We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT ...

  • SBRT for Oligometastatic Castration-Refractory Prostate Cancer Rochester, MN

    Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with <=3 metastatic="" lesions="" will="" receive="" stereotactic="" body="" radiotherapy="" (sbrt)="" as="" definitive="" treatment.="" blood="" draws="" will="" be="" taken="" to="" monitor="" the="" development="" of="" anti-prostate="" cancer="">

  • A Study to Test the Addition of berzosertib to Usual Radiation Treatment for Chemotherapy-Resistant Breast Cancer Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to determine the recommended Phase 2 dose twice weekly of berzosertib administered concurrently with conventionally fractionated radiation therapy to the breast/chest wall and regional nodes.

  • Study Comparing Thin Dressings to Prevent Skin Inflammation in Breast Cancer Patients Rochester, MN

    We are doing this research study to compare radiation dermatitis severity in exposed skin protected by a thin film dressing versus skin that is not protected during radiation treatment. We will also be comparing two types of film; a perforated thin film dressing versus the standard thin film.

  • A Study of Bladder Filling Variations During Radiation Therapy in Patients Undergoing Radiation Treatment for Prostate Cancer Jacksonville, FL

    The purpose of this study is to examine bladder filling for radiation treatment to the prostate, and to evaluate how bladder fullness changes daily during radiation treatment.  

  • Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients with Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System Rochester, MN

    This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare ...

  • A Study of Combination Radiation Therapy and Cisplatin with or without Triapine for Treating Patients with Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer Jacksonville, FL; Rochester, MN

    The purpose of this study is to see how well radiation therapy and cisplatin with triapine work in combination compared to the standard radiation therapy and cisplatin alone to treat patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Triapine may stop the growth of tumor cells ...

  • survey with parents of children who had proton treatment for brain tumors Rochester, MN

    The overall goal of this project is to survey parents of children who have undergone proton radiation for brain tumors and collect key information that will improve the feasibility of our proposed intervention.  The survey will include questions on experience with proton treatment and opinion regarding a proposed early intervention.

  • A Study to Evaluate Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment for Stage I-IIIA Malignant Pleural Mesothelioma Rochester, MN

    The purpose of this study is to determine how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery ...

  • Radiation Therapy, Paclitaxel, and Carboplatin with or without Trastuzumab in Treating Patients with Esophageal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to ...

  • Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer Jacksonville, FL; Rochester, MN

    This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells ...

  • A Study to Establish a Platform for Managing Pancreatic Adenocarcinoma Using Patient-derived Tumoroids Jacksonville, FL

    The purposes of this study are to determine the optimal patient-derived tumoroid (PDT) model, to determine the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach, to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish PDT as a platform for a personalized approach to guide multimodality treatment. 

  • A Study to Determine the Treatment Outcomes and Toxicity of Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy Rochester, MN

    The purpose of this study is to determine if intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rates and lowered toxicity compared to conventional radiotherapy. Data from retrospective studies suggest that IMRT and proton radiation therapy each resulted in promising outcomes for patients with sinonasal malignancy. No previous prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy.

    The study would also assess if proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT.  It is not known if ...

  • A Study to Evaluate Proton Therapy to Treat Low-Grade Glioma Rochester, MN

    The purpose of this study is to determine the feasibility of hippocampal-avoidance (HA) with proton therapy in suprasellar or midline low-grade gliomas (LGGs). 

  • A Study to Analyze Hypofractionated Proton Therapy for Head and Neck Cancers Scottsdale/Phoenix, AZ; Rochester, MN

    This study aims to determine overall survival, progression free survival, local, regional, distant recurrence risks, and infield and outfield recurrence in the trial at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events and estimate acute toxicity burden using T-score and to determine the incidence of secondary acute effects attributable to radiotherapy including incidence of PEG tube placement, duration and dose of narcotic analgesia required, weight loss, and hospitalization days.

  • High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery Rochester, MN; La Crosse, WI

    This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...

  • Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer Rochester, MN

    This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.

  • Outcomes for Hand and Foot Soft Tissue Sarcomas Treated with Limb Sparing Multimodal Therapy Rochester, MN

    Goals:

    1. Report and describe patient-reported functional outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    2. Describe radiotherapy volumes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    3. Report local control outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    4. Report survival outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

  • Characterizing Heart Changes Related to Chemo-Radiotherapy Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the 12-month cardiac event rate  after radiation or chemo-radiation for the treatment of lung or esophageal cancer.

  • Hypofractionated Radiotherapy After Breast Conserving Surgery Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.

  • A Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS) Rochester, MN

    The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.

  • Fertility Outcomes in Lymphoma Patients Jacksonville, FL

    The objectives of this study are to analyze impact of radiation on fertility, to correlate the clinical outcome of fertility after chemotherapy and or radiation, and to evaluate the different modalities and cost/benefit of fertility preservation in lymphoma patients

    Lymphoma is a diversified disease with outcomes differing upon the types and subtypes of lymphoma as well as treatment modalities used. Fertility outcomes in patients treated with chemotherapy and/or radiation could vary and largely unknown.

  • Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery Eau Claire, WI

    The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...

  • A Study to Evaluate the Adaptive Image Receive (AIR) Coil System for Patients Undergoing MR Imaging Simulation Rochester, MN

    This study is designed to assess the ergonomics and ease of use of a new Adaptive Image Receive (AIR) coil system for patients undergoing MR imaging for radiation therapy treatment planning. 

  • Phase II Trial of Standard Chemotherapy +Various Proton Beam Therapy (PBT) Doses for Unresectable Stage 2/3 Non-Small Cell Lung Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    This study is being done to study which dose of proton beam therapy (PBT) for unresectable stage 2/3 Non-Small Cell Lung Cancer.

  • A Registry for Children Treated with Proton Radiation Therapy Rochester, MN

    The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.

  • A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to observe adverse events and effectiveness of hypofractionated concurrent chemoradiotherapy for the treatment of pancreatic cancer.

     

  • A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL

    This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.

  • A Consortium Trial to Evaluate Proton vs. Photon Therapy for Patients with Non-metastatic Breast Cancer Jacksonville, FL

    The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.

     

  • A Study of Intratumoral Injection of Dendritic Cells after High-Dose Conformal External Beam Radiotherapy in Patients with Unresectable Liver Cancer Rochester, MN

    The primary purpose of this study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).

  • A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this trial is to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.

  • Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma Rochester, MN

    This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving ...

  • A Study to Evaluate Chemoradiotherapy with or without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer La Crosse, WI; Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.

  • A Study of T-VEC and Radiation to Treat Localized Soft Tissue Sarcoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.

  • A Study to Evaluate Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer Rochester, MN

    The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.

  • Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer Mankato, MN

    RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.

    PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

  • A Study to Evaluate Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant Rochester, MN

    The purpose of this study is to compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.

  • Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial Rochester, MN

    A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020."

  • Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis Eau Claire, WI; Rochester, MN

    The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.

  • A Study of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.

  • Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer Eau Claire, WI; Mankato, MN; Rochester, MN; Jacksonville, FL

    This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

  • A Study to Evaluate M7824 with Concurrent Chemoradiation (cCRT) in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Rochester, MN

    The primary purpose of this study is to evaluate safety and effectiveness in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

  • A Study to Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN

    The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...

  • Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN

    The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...

  • Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer Scottsdale/Phoenix, AZ

    This randomized clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. After the surgery, patients are randomized to receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.

  • Patient Outcomes following Artificial Urinary Sphincter Placement in Male Patients Rochester, MN

    The purpose of this study is to create a Mayo Clinic AUS research database with follow-up through 4 months.  To eventually evaluate other risk factors for AUS complications, including prior treatments, comorbidities and obesity.

  • A Study to Compare Acute Toxicities between Patients Treated with Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).

  • A Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer Rochester, MN

    Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

  • Proton or Photon RT for Retroperitoneal Sarcomas Rochester, MN

    This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.

    Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, ...

  • Evaluating the Impact of 18F-DOPA-PET on Radiotherapy Planning for Newly Diagnosed Gliomas Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to use a nutrient called 18F-FDOPA and PET/CT scan to help determine where and how big the tumor is, as well as how aggressive the tumor is. This will help treating physicians to target diseased areas with higher than standard doses of radiation, in order to improve the effectiveness of radiation in this tumor.

  • Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer Scottsdale/Phoenix, AZ; Rochester, MN; La Crosse, WI; Eau Claire, WI

    This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.

  • A Study to Evaluate Optune vs. Prophylactic Cranial Irradiation (PCI) in Non-Small Cell Lung Cancer Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases.  Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity.  As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression ...

  • Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

  • Determining Molecular Drivers of Radiation Dermatitis Jacksonville, FL

    The purpose of this study is to collect (i) pre-treatment (at the time of breast cancer surgery) normal skin and (ii) on-treatment (around the third week of treatment with breast radiation) irradiated skin with clinical hallmarks of radiation dermatitis (erythema and/or dry desquamation, documented by a photograph and graded by clinical criteria).

  • Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

  • Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) with Avelumab in Muscle Invasive Bladder Cancer No Locations

    The purpose of this study is to evaluate the complete response rate of concurrent chemotherapy radiation treatment combined with avelumab for patients with muscle invasive bladder cancer.

  • A Study to Evaluate Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC Scottsdale/Phoenix, AZ

    The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

  • Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery Albert Lea, MN; Mankato, MN; Rochester, MN

    This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or ...

  • A Study to Compare Proton Therapy to Photon Radiation Therapy for Esophageal Cancer Albert Lea, MN; Eau Claire, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to evaluate how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in ...

  • A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Rochester, MN

    The purpose of this study is to assess late > grade 3 GI and/or GU toxicity of interest with the hypofractionated regimen with proton beam therapy or IMRT (late defined as 3 to 24 months after protocol RT).

  • A Study Comparing Proton and Photon Radiation Outcomes in Prostate Cancer Patients Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN

    The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).

  • A Study to Compare Administering Olaparib Concurrently With Radiotherapy vs. Radiotherapy Alone in Treating Patients With Inflammatory Breast Cancer La Crosse, WI; Eau Claire, WI; Rochester, MN

    The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

  • Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery Rochester, MN; Scottsdale/Phoenix, AZ

    This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue and can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping ...

  • A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma Rochester, MN

    Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).

    Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...

  • A Study to Evaluate the Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer Scottsdale/Phoenix, AZ

    The purpose of this study is to investigate whether pembrolizumab (MK-3475 ) can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer. Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.

  • Radiation Therapy with Durvalumab or Cetuximab to Treat Patients with Locoregionally Advanced Head and Neck Cancer who Cannot Take Cisplatin Rochester, MN

    This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab or cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation ...

  • Study of BN Brachyury and Radiation in Advanced Chordoma Patients Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity will be needed to proceed to stage 2.

  • A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy Jacksonville, FL

    This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.

  • Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...

  • A Study to Evaluate CHIP and Hematological Toxicity After PRRT in Neuroendocrine Tumor Patients Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to combine robust clinical data (e.g., prior chemotherapy or radiation exposure, cumulative Peptide Receptor Radionuclide Therapy (PRRT dose)) with genetic and clonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in PRRT-treated neuroendocrine tumor (NET) patients.

  • A Study to Evaluate the Safety and Effectiveness of ICMGA00012 and Epacadostat Combined with Radiation and Bevacizumab in Recurrent Glioma Patients Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.

  • Breast-Conserving Surgery and Radiation Therapy in Patients with Multiple Ipsilateral Breast Cancer Rochester, MN

    RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

    PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

  • Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma Rochester, MN

    RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

    PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central ...

  • A Study to Evaluate the Optune® (Tumor Treating Fields) Concomitant with RT & TMZ to Treat Newly-diagnosed Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

  • Testing Nivolumab and Ipilimumab With Short-Course Radiation in Advanced Rectal Cancer Rochester, MN

    The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.

  • A Study to Evaluate Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma Rochester, MN

    The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.

  • A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.

  • Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN

    This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

  • A Study to Compare Single Fraction Stereotactic Radiosurgery Compared with Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to compare how well single fraction stereotactic radiosurgery works versus fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time.

  • Stereotactic Body Radiation Therapy in Treating Patients with Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer Rochester, MN

    This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.

  • A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy Rochester, MN

    The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.

     

  • A Study to Evaluate Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Eau Claire, WI

    The purpose of this study is to evaluate androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.  Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

  • Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.

    PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

  • A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity Jacksonville, FL

    This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

  • Radiation Therapy and Docetaxel in Treating Patients with HPV-Related Oropharyngeal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with docetaxel my kill more tumor cells.

  • A Study to Evaluate Chemotherapy and Radiation Therapy With or Without Surgery to Treat Patients With Head and Neck Cancer Rochester, MN

    The purpose of this study is to determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC, to assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens, to define the acute and late toxicity of each treatment regimen, to evaluate whether there are differences in patient’s QOL, perception of side effects, and performance status between treatment arms, to establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation.

     

  • Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN

    This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

  • Use of Navigator Echoes for 4D-MRI Rochester, MN

    The general aim of this proposal is to evaluate new non-significant risk (NSR) MRI technology in a clinical setting, specifically the use of preclinical (non-FDA-approved) sequences (including but not limited to bSSFP, SSFSE) which have been modified from their standard counterparts to include interleaved 1D body navigator pulses.

  • EORTC-1709-BTG_CCTG-CE.8: A Study to Compare Marizomib in Combination with Standard Radiochemotherapy vs. Radiochemotherapy Alone in Patients with Newly- diagnosed Glioblastoma MIRAGE Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the safety and tolerability of marizomib in combination with Temozolomide-based radiochemotherapy versus standard Temozolomide-based radiochemotherapy alone in newly diagnosed glioblastoma patients. 

  • Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer La Crosse, WI

    This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy ...

  • A Study to Evaluate Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer La Crosse, WI

    The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area in patients with prostate cancer to find out which is better.

  • Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma Scottsdale/Phoenix, AZ; Rochester, MN

    To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.

    a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

    b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

    c. ...

  • A Study to Evaluate Stereotactic Radiosurgery Versus Hippocampal-Avoidant Whole Brain Radiotherapy for 10 or Fewer Brain Metastases from Small Cell Lung Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The primary objective of this study is to determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT). 

  • A Study to Evaluate Treatment of Papillary Thyroid Carcinoma with Radiofrequency Ablation Rochester, MN

    The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

  • Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery Eau Claire, WI

    RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

  • A Study to Compare Whole Brain Radiotherapy and Memantine to Stereotactic Radiosurgery vs. Stereotactic Radiosurgery Alone to Treat Patients with Cancer That Has Spread to the Brain After Earlier Stereotactic Radiosurgery Jacksonville, FL

    The purpose of this study is to compare the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory.

    The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on ...

  • Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer Rochester, MN

    The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.

  • SPORT-DMG Rochester, MN

    The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.

    Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study

  • Hypofractionated Radiation Therapy in Treating Participants With Prostate Cancer High-Risk Features Following Radical Prostatectomy Scottsdale/Phoenix, AZ; Rochester, MN

    This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

  • 18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain Jacksonville, FL

    The goal of this study is to further evaluate the ability of fluciclovine PET to discriminate between radiation necrosis and tumor progression in patients with previously irradiated intracranial metastatic disease. 

  • A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors Rochester, MN

    The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.

  • Coronary CTA for Radiation Therapy Planning in Lymphoma Patients Rochester, MN

    Our purpose for this study is to help design a therapy plan that can decrease extra radiation exposure to your heart during radiotherapy. The therapy plan will use images obtained using a dual-source CT scanner

  • Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL

    This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance ...

  • FRACTIONATE Rochester, MN; Scottsdale/Phoenix, AZ

    All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately.  The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials.  Although this cohort was enrolled on the prospective phase I trial from ...

  • A Study to Evaluate Mindfulness Intervention During Radiotherapy Rochester, MN

    The purpose of this study is to evaluate the effectiveness of a mindfulness-based intervention (MBI) on subjective reports of wellness including emotional, physical, functional, and social domains during radiotherapy for the treatment of cancer.

  • A Study to Compare Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy Jacksonville, FL; Rochester, MN

    The puropse of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

  • Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy Jacksonville, FL; Rochester, MN; Albert Lea, MN; Mankato, MN

    This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

  • A Study of Standard of Care Therapy, with or without the Addition of Stereotactic Radiosurgery and/or Surgery, for Treating Patients with Limited Metastatic Breast Cancer Rochester, MN; Jacksonville, FL

    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic ...

  • Pembrolizumab, Chemotherapy, and Radiation Therapy With or Without Surgery in Treating Patients With Anaplastic Thyroid Cancer Rochester, MN

    This phase II trial studies how well pembrolizumab, chemotherapy, and radiation therapy work with or without surgery in treating patients with anaplastic thyroid cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as docetaxel and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, chemotherapy, and radiation therapy with or without surgery ...

  • A Study to Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.

  • Eliminating Breast Cancer Surgery in Exceptional Responders with Neoadjuvant Systemic Therapy Rochester, MN

    The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.

  • Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy Mankato, MN

    This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

  • Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer Scottsdale/Phoenix, AZ

    This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.

  • Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk Rochester, MN

    We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...

  • A Study of Using Geometrically Accurate Functional MRI to Enable Personalized Radiotherapy of Glioblastoma Scottsdale/Phoenix, AZ

    The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma.  MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.

  • LS138D, Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma Rochester, MN

    This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab is more effective with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.

  • A Study to Evaluate Left and Right Ventricular Function in Relation to Exercise Capacity in Breast Cancer Survivors Jacksonville, FL

    The purpose of this study is to determine if exercise improves cardiac remodeling as a way to mitigate the negative effects of chemotherapy and radiation therapy which lead to reduced exercise tolerance.

  • A Study to Assess Accelerated Resolution Therapy for Cancer Related Trauma and Distress Jacksonville, FL; Rochester, MN

    The purpose of this study is to quantitatively evaluate accelerated resolution therapy (ART) for treatment of cancer distress and psychological trauma.

  • SBRT with Immunotherapy for Mesothelioma Rochester, MN

    The purpose of this study is to evaluate whether adding stereotactic body radiation therapy (SBRT) to immunotherapy as part of second line treatment for mesothelioma will improve the modest response rate of immunotherapy alone, provide local control/cytoreduction to sites of gross disease, and decrease symptomatic burden while improving outcomes.

     

     

  • A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients Rochester, MN

    The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.

     

  • Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial Scottsdale/Phoenix, AZ

    A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.

  • A Study of Nivolumab and Multi-fraction Stereotactic Radiosurgery with or without Ipilimumab in Treating Participants with Recurrent Grade II-III Meningioma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...

  • A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients Rochester, MN

    The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy  (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).

  • Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radiation Injury After Treatment for Brain Metastases Rochester, MN

    This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

  • Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases Rochester, MN

    Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.

  • Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors Rochester, MN

    Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells

    This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.

  • A Study to Evaluate Treating Post-Mastectomy Radiation Injury in Breast Cancer Patients with Adipose-Induced Regeneration of Breast Skin (AIR Breast) Jacksonville, FL

    The primary purpose of this study is to identify the therapeutic effect of Adipose-Induced Regeneration (AIR) in radiation-induced skin injury of post-mastectomy breast cancer patients.

  • A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy Rochester, MN

    The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods. 

  • The NeoGlioma Study Jacksonville, FL

    This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.

  • Pre-operative vs. Post-operative Radiosurgery for Metastatic Brain Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.

     

  • A Study to Determine the Effects of COVID-19 in Cancer Patients Scottsdale/Phoenix, AZ; Mankato, MN; La Crosse, WI; Eau Claire, WI; Rochester, MN

    The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

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