Radiation Therapy in Treating Patients With Recurrent Breast Cancer
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|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||Phase|
|Breast Cancer||Radiation: intracavitary balloon brachytherapy Radiation: intraoperative radiation therapy||Not Applicable|
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|