Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
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.
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: intraoperative radiation therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer|
- Feasibility [ Designated as safety issue: No ]
- Acute tolerability [ Designated as safety issue: Yes ]
- Local tumor control rate [ Designated as safety issue: No ]
- Distant tumor control rate [ Designated as safety issue: No ]
- Long-term side effects [ Designated as safety issue: Yes ]
- Cosmetic outcome [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647582
|Study Chair:||William W. Wong, MD||Mayo Clinic|