Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: adjuvant therapy
* Procedure: therapeutic conventional surgery
* Radiation: intraoperative radiation therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary invasive breast carcinoma, meeting the following criteria: Stage I or II disease (T1-T2, N0, M0) Tumor pathologically determined to be ≤ 5 cm in diameter Single, discrete, well-defined primary tumor No multicentric disease and/or diffuse malignant appearing microcalcifications Any microcalcifications must be focal Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications No axillary lymph node involvement Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling Must have pathologically negative surgical margins No evidence of metastatic breast cancer Hormone receptor status not specified PATIENT CHARACTERISTICS: ECOG performance status 0-2 Menopausal status not specified Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy PRIOR CONCURRENT THERAPY: No prior irradiation to the area of planned radiation field Concurrent hormone therapy allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|nan|
|Procedure: therapeutic conventional surgery|nan|
|Radiation: intraoperative radiation therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Acute tolerability |  |  | 
| Local tumor control rate |  |  | 
| Distant tumor control rate |  |  | 
| Long-term side effects |  |  | 
| Cosmetic outcome |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer