Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy|
- To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
- To evaluate the rate and severity of acute skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the rate and severity of radiation pneumonitis, a sub-acute toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the rate and severity of late skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate cosmetic outcome and patient satisfaction with cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To evaluate acute and late toxicity of breast reconstruction following proton radiation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the need for unplanned additional surgery for breast reconstruction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To evaluate early signs of cardiac effects from radiation therapy using Strain Echocardiogram [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]To describe the 5 year progression free survival rate of patients with breast cancer treated with proton radiation
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Proton Radiation
Radiation therapy with proton beam
Radiation: Proton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340495
|Contact: Shannon M MacDonald, M.D.||email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Shannon M MacDonald, MD|
|Principal Investigator:||Shannon M MacDonald, M.D.||Massachusetts General Hospital|