Samir H. Patel, M.D.

Closed for Enrollment

• A Phase II Study of Accelerated 3 Fraction Photon and Proton Partial Breast External Beam Radiotherapy and Partial Breast Brachytherapy for Early Invasive and Noninvasive Breast Cancer Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  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 Randomized Clinical Trial to Study the Utility of Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy in American Indian and Alaska Native Individuals (VIEW study) (VIEW) Scottsdale/Phoenix, Ariz.

  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.

   

   

• A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning versus Standard Radiation Treatment Planning (GMROR2371) Rochester, Minn., Mankato, Minn., La Crosse, Wis., Jacksonville, Fla., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

  The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.

• A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the clinical outcomes of lower intensity (mucosal tissue sparing) proton beam therapy after the surgical removal of oropharyngeal tumors in cancer patients who have a favorable level of risk.

• A Validation Study of Deep Learning-based Automated Segmentation of Organs at Risk (OARs) in Head and Neck (H&N) Radiotherapy Rochester, Minn.

  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.

• DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy (GMROR2271) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The primary goal of this study is to prospectively incorporate ctHPVDNA in combination with clinical and pathologic factors to appropriately select patients for treatment intensity. 

• DART-HPV: A Phase III Evaluation of De-escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer Rochester, Minn., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz.

  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.

• MC1974: A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Of Unknown Primaries (HNCUP) Rochester, Minn., Scottsdale/Phoenix, Ariz.

  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.

• Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  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.

• Phase III 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, Minn., Scottsdale/Phoenix, Ariz.

  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.

• ROR1771: A Prospective Observational Study of Proton Stereotactic Body Radiation Therapy and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.