Radiation Therapy During Surgery in Treating Older Women With Stage I 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 intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.

Detailed Description
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OBJECTIVES: Primary Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer. Secondary Study the impact of this regimen on maintaining self-care. Study the quality of life (QLQ-C30) and satisfaction with care. Study regimen tolerance and cosmetic results. Evaluate the economic impact of this treatment. Study relapse-free and disease-specific survival. OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast. Patients may begin hormonal therapy after completing study therapy. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Official Title
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Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: axillary lymph node dissection
* Procedure: conventional surgery
* Procedure: sentinel lymph node biopsy
* Radiation: intraoperative radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Inclusion criteria: Histologically confirmed stage I breast cancer Size ≤ 20 mm (by ultrasound), N0, any quadrant Hormone receptor status not specified Exclusion criteria: Distant metastases Inflammatory breast cancer Lobular in situ disease Invasive cancer or ductal carcinoma in situ Nonepithelial disease or sarcoma Multicentric disease Lymphatic embolism Margins of safety unknown or positive (in situ or invasive) Preoperative mammography showing diffuse microcalcification PATIENT CHARACTERISTICS: Female Menopausal Karnofsky 70-100% No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years No geographic, social, or psychiatric reasons that would impede participation in study treatment PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior neoadjuvant therapy No concurrent participation in another study

Ages Eligible for Study
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Minimum Age: 65 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
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: axillary lymph node dissection|nan|
|Procedure: conventional surgery|nan|
|Procedure: sentinel lymph node biopsy|nan|
|Radiation: intraoperative radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Reproducibility |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QLQ-C30) |  |  | 
| Satisfaction with care |  |  | 
| Tolerability |  |  | 
| Cosmetic results |  |  | 
| Economic impact |  |  | 
| Relapse-free survival |  |  | 
| Disease-specific survival |  |  | 

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