Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates
OBJECTIVES:
- Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute
complications after lumpectomy (before whole breast irradiation) in women with ductal
carcinoma in situ or invasive adenocarcinoma of the breast.
- Determine the local recurrence rates in patients treated with this regimen.
- Determine the cosmetic outcome in patients treated with this regimen.
OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of
radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy
to the entire breast 5 days a week for 5-6 weeks.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
Patients are followed at 1 month and then every 3 months for 2 years
No
Shelli Hanks, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
ICC4102
NCT00054301
November 2002
October 2004
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |