Radiation Therapy in Treating Patients With Recurrent Breast Cancer
|ClinicalTrials.gov Identifier: NCT00945061|
Recruitment Status : Active, not recruiting
First Posted : July 23, 2009
Last Update Posted : January 30, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Radiation: intracavitary balloon brachytherapy Radiation: intraoperative radiation therapy|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 23, 2008|
|Estimated Primary Completion Date :||May 22, 2018|
|Estimated Study Completion Date :||May 22, 2018|
Experimental: Group 1
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Radiation: intraoperative radiation therapy
Patients undergo radiotherapy
Experimental: Group 2
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Radiation: intracavitary balloon brachytherapy
Patients undergo brachytherapy
- Ipsilateral breast tumor recurrence rates [ Time Frame: Every three months during the first year and every 6 months thereafter for 5 years. ]
- Tumor bed recurrence rates [ Time Frame: Every three months during the first year and every 6 months thereafter for 5 years. ]
- Cosmetic outcome as determined by an established scale [ Time Frame: 1 month after RT & Q3mos for one year and at 5 years ]
- Patient satisfaction with the procedure as determined by a patient questionnaire [ Time Frame: one month post-radiation therapy, and every three months thereafter for one year, followed bi-annually for the remainder of the 5 year follow-up. ]
- Wound healing and overall complication rate [ Time Frame: one month post-radiation therapy, and every three months thereafter for one year, followed bi-annually for the remainder of the 5 year follow-up. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945061
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|UHHS Chagrin Highlands Medical Center|
|Cleveland, Ohio, United States, 44122|
|UHHS Westlake Medical Center|
|Cleveland, Ohio, United States, 44145|
|Principal Investigator:||Janice Lyons, MD||University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|