Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for 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 after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer. Secondary Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients. Determine relapse-free survival of patients treated with this regimen. Determine overall and specific survival of patients treated with this regimen. Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients. Determine the direct and indirect costs of this regimen in these patients. OUTLINE: This is a multicenter, open-label, nonrandomized study. Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Official Title
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Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

Conditions
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Breast Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of invasive breast cancer Stage I or II disease Tumor size ≤ 30 mm Located in any breast quadrant No nodal involvement No inflammatory breast cancer No positive margins after surgical resection (performed on study) No microcalcifications Hormone receptor status Not specified PATIENT CHARACTERISTICS: Age Over 70 Sex Female Menopausal status Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentrated and Focalized Radiotherapy<br> | Procedure: adjuvant therapy<br> <br> Procedure: conventional surgery<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score |  | 3 weeks | 
| Relapse-free survival |  | 1 year | 
| Overall and specific survival |  | 1 year | 
| Cosmetic result |  | 1 year | 
| Direct and indirect costs |  | 1 month | 

 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