NCT00945061

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	intracavitary balloon brachytherapy	Patients undergo brachytherapy
RADIATION	intraoperative radiation therapy	Patients undergo radiotherapy

Timeline

• Start date: 2008-09-23
• Primary completion: 2018-07-06
• Completion: 2018-07-06
• First posted: 2009-07-23
• Last updated: 2020-08-18
• Results posted: 2020-08-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study