Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Conditions
Invasive Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast Cancer, Mastectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Proton Radiation
Type: Radiation
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics

- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery

- Life expectancy > 12 months

Exclusion Criteria:

- Pregnant or breast-feeding

- Prior therapeutic radiation > 200 cGy

- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin

- Prior investigation chemotherapy
Location
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Start Date
June 2011
Sponsors
Massachusetts General Hospital
Source
Massachusetts General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page