Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
Proton Collaborative Group
Summary
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Description
This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.
Eligibility
- Age range
- 19+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN) * Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended * Documentation of…
Interventions
- RadiationProton Therapy
Pencil Beam Scanning (PBS)
Locations (7)
- Mayo ClinicScottsdale, Arizona
- California Protons Cancer Therapy CenterSan Diego, California
- University of Florida Proton Therapy InstituteJacksonville, Florida
- Miami Cancer InstituteMiami, Florida
- Emory Proton Therapy CenterAtlanta, Georgia
- New York Proton CenterNew York, New York