Breast Cancer Clinical Trial
Official title:
Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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