Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be
assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12
months, and then every year for up to five years after treatment. Follow-up visits will
include a physical examination, radiological imaging (if necessary), echocardiogram, and
laboratory tests.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 toxicity within 3 months after the completion of radiation treatment.
5 years
Yes
Shannon M MacDonald, M.D.
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
10-205
NCT01340495
June 2011
Name | Location |
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Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |