Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Determination of which patients are best suited for each individual technique of partial breast irradiation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
Detailed Description
OBJECTIVES: * To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques. * To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire. * To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique. * To evaluate wound healing and overall complication rate after partial breast irradiation. * To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates. OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days. After completion of study therapy, patients are followed periodically for up to 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Determination of which patients are best suited for each individual technique of partial breast irradiation
Time Frame: Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
Time Frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Wound healing and overall complication rate after partial breast irradiation
Time Frame: 1 month after RT & Q3mos for one year
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Time Frame: 1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire
Time Frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr