Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Start Date
2/1/2013
Completion Date
1/1/2035
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.
Detailed 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 underway comparing partial breast irradiation (PBI) to whole breast irradiation. Numerous centers are offering partial breast irradiation outside of clinical trials as well, despite the lack of long-term safety and efficacy data on PBI. Available PBI methods include brachytherapy, in which catheters or balloons are surgically inserted to deliver radiation therapy to the lumpectomy cavity, and conventional external beam radiation therapy, or EBRT. External beam photon therapy is attractive for its non-invasive nature and ability to deliver a more homogenous dose distribution compared to brachytherapy, however it also delivers a greater radiation dose to surrounding normal breast tissue.Proton therapy has the capacity to provide the same advantages as photon EBRT while minimizing dose to normal surrounding tissue. Clinical data on PBI with protons is minimal, however, leaving many questions unanswered. The impetus behind this protocol is to address these gaps by further investigating the feasibility, safety, and efficacy of proton therapy for partial breast irradiation.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
Proton Radiotherapy
Conditions
Locations
Mayo Clinic
Scottsdale, Arizona 85259
United States
California Protons Cancer Therapy Center
San Diego, California 92121
United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois 60555
United States
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United States
McLaren Proton Therapy Center
Flint, Michigan 48532
United States
New York Proton Center
New York, New York 10035
United States
Oklahoma Proton Center
Oklahoma City, Oklahoma 73142
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Hampton University Proton Therapy Institute
Hampton, Virginia 23666
United States