Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00647582
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.
- Detailed Description
OBJECTIVES:
* To determine the feasibility and acute tolerability of intraoperative electron radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women with stage I or II breast cancer treated with breast conservation therapy.
* To determine the local tumor control and distant tumor control rates in these patients.
* To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed and EBRT after lumpectomy in these patients.
OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.
After completion of study treatment, patients are followed periodically for up to 8 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute tolerability Feasibility Local tumor control rate Distant tumor control rate Cosmetic outcome Long-term side effects
- Secondary Outcome Measures
Name Time Method