Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- UNICANCER
- Enrollment
- 46
- Locations
- 10
- Primary Endpoint
- Reproducibility
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reproducibility
Time Frame: 1 month
Secondary Outcomes
- 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)