Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Proton Collaborative Group
Summary
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Description
Current standard of care for early stage breast cancer is mastectomy or breast conserving therapy with whole breast irradiation following lumpectomy. However, studies of breast cancer recurrence have demonstrated the majority of tumors to recur in or adjacent to the original tumor site. The question has thus been raised as to whether radiation to the whole breast is necessary or justified. Limiting radiation to the area of the original tumor may reduce acute and long-term skin and organ toxicities while making radiation therapy more convenient and less expensive. Several clinical trials are un…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial. * Must be female. * Must be \> = 50 years of age. * Must have a life expectancy of at least 5 years based on age and co-morbidities. * Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS). * One of the following criteria must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed withi…
Interventions
- RadiationProton Radiotherapy
Locations (9)
- Mayo ClinicScottsdale, Arizona
- California Protons Cancer Therapy CenterSan Diego, California
- Northwestern Medicine Chicago Proton CenterWarrenville, Illinois
- Maryland Proton Treatment CenterBaltimore, Maryland
- McLaren Proton Therapy CenterFlint, Michigan
- New York Proton CenterNew York, New York