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Clinical Studies


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  • A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer Rochester, Minn.

    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 Pilot Study Comparing Thin Film Dressings for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients Rochester, Minn.


    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.

  • Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients Rochester, Minn.

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

  • MC1973: A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz. 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 rates and oncologic outcomes, as compared to historical standards.
  • Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas (12-100) Rochester, Minn.

    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, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.

    Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation.

    In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.

    The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.

  • ROR1781:Patient-reported Functional Outcomes for Hand and Foot Soft Tissue Sarcomas Treated with Limb Sparing Multimodal Therapy Rochester, Minn.


    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.