Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
- To determine the in breast recurrence rate following repeat radiation to the breast
with Mammosite® brachytherapy or intraoperative radiotherapy in patients with recurrent
ipsilateral breast cancer.
- To determine the cosmetic outcome resulting from partial breast re-irradiation using
different techniques, including both physician- and patient-rated scales.
- To determine patient satisfaction of partial breast re-irradiation as it pertains to
their overall treatment experience, as measured by a questionnaire.
- To determine if there are patient factors which limit a patient's suitability to
receive partial breast re-irradiation delivered by a particular technique.
- To evaluate tylectomy wound healing and overall complication rate after partial breast
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients are stratified according to which modality is best suited for the patient.
Patients are assigned to 1 of 2 groups.
All patients undergo excisional biopsy or needle localization removal of the tumor. Patients
with margins < 2 mm undergo re-excision of the biopsy cavity.
- Group 1: Patients undergo partial breast irradiation delivered as a single
intra-operative radiation dose to the tumor bed.
- Group 2: Patients undergo partial breast irradiation delivered by Mammosite®
brachytherapy consisting of 10 fractions over 5 days.
Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then
at follow-up visits.
After completion of study treatment, patients are followed up at 1 month, every 3 months for
1 year, and then every 6 months for 5 years.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ipsilateral breast tumor recurrence rates
Every three months during the first year and every 6 months thereafter for 5 years.
Janice Lyons, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|