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Proton vs Photon

Pragmatic Phase III Randomized Trial Of Proton Vs. Photon Therapy For Patients With Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina; Frankos, Marie; Tan, Ciara Natasha

  • IRB No: 16.126.10

    Protocol Abbrev: RADCOMP

    Principal Investigator: Tomas Dvorak, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: RADCOMP

    Treatment: Radiation: Photon and Radiation: Proton

    Therapies Involved: Radiation

    ClinicalTrials.gov ID: NCT02603341

  • Objective

    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).

  • Key Eligibility

    •   Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
    •   Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
    •   Must have a pertinent history/physical examination within 90 days prior to registration.
    •   Age ≥ 21 years
    •   Negative pregnancy test
    •   ECOG Performance Status 0 – 2
    •   Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.