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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
Time Frame: During the treatment of irradiation (4 weeks)
feasibility based on dosimetric criteria based on the Quality Index of the application.
Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
Time Frame: During the treatment of irradiation (4 weeks)
reproducibility based on dosimetric criteria based on the Quality Index of the application.
Secondary Outcomes
- impact on Quality of life of partial irradiation of the breast by per-operative electron therapy(from the baseline to 12 months after the treatment)
- Tolerability of partial irradiation of the breast by per-operative electron therapy(from the baseline to 12 months after the treatment)
- Relapse-free survival(from the baseline to 12 months after the treatment)
- Disease-specific survival(from the baseline to 12 months after the treatment)