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NCT number NCT00945061
Study type Interventional
Source Case Comprehensive Cancer Center
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Status Active, not recruiting
Phase N/A
Start date September 23, 2008
Completion date May 22, 2018

Clinical Trial 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.


Clinical Trial Description

OBJECTIVES:

- 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 re-irradiation.

- 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.


Study Design


Related Conditions & MeSH terms


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