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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Institut Bergonie
Bordeaux, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Centre Antoine Lacassagne
Nice, France
Reproducibility
Time frame: 1 month
Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score
Time frame: 3 weeks
Relapse-free survival
Time frame: 1 year
Overall and specific survival
Time frame: 1 year
Cosmetic result
Time frame: 1 year
Direct and indirect costs
Time frame: 1 month
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Hopital Saint-Louis
Paris, France
CHU Pitie-Salpetriere
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Paul Strauss
Strasbourg, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France