Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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