Breast Cancer Clinical Trial
Official title:
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
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. It is not yet known whether a single dose of radiation therapy is more effective
than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works
compared with radiation therapy during surgery in treating patients with recurrent breast
cancer.
OBJECTIVES:
- To determine the in breast recurrence rate following repeat radiation to the breast.
These patients will be followed for a period of five years following completion of
radiation to determine these rates.
- 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 illuminated during a discussion of informed
consent, 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
re-irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence
rates.These patients will be followed for a period of five years following completion of
the second course of radiation to determine these 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.
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