Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00647582|
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: intraoperative radiation therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||December 21, 2013|
- Acute tolerability
- Local tumor control rate
- Distant tumor control rate
- Long-term side effects
- Cosmetic outcome
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): NCT00647582
|Study Chair:||William W. Wong, MD||Mayo Clinic|