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Clinical Studies

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  • A Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery (MC1635) Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    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 Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy Rochester, Minn.

    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.

  • Case Report of Severe Fibrosis after Breast Radiation Rochester, Minn.

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

  • Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis Rochester, Minn., Eau Claire, Wis.

    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.

  • Genomic Assessment of Patients With Severe Radiation Reactions Rochester, Minn.

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

  • NRG-BR002, A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer Rochester, Minn., Jacksonville, Fla.

    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 body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

  • Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction Rochester, Minn., Mankato, Minn., Jacksonville, Fla., Eau Claire, Wis.

    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.

  • ROR2103: Patient Reported Outcomes in Radiation Therapy (PRO-RT) (PRO-RT) Rochester, Minn.

    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 Electronic Health Record (EHR).  The department of Radiation Oncology has invested years of time and resources developing a Radiation Oncology outcomes database. This dataset is a compilation of clinical details, radiation dose/plan characteristics, patient and clinician reported toxicities, and cancer specifics which is integrated into the Mayo Clinic Unified Data Platform.  However, critical gaps exist in the completeness of toxicity and patient reported outcomes information.  

     

     

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