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
- Study the feasibility and reproducibility of intraoperative radiotherapy as the only
treatment after lumpectomy in older women with stage I breast cancer.
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Jean-Bernard Dubois, MD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government