Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer
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.
Procedure: axillary lymph node dissection
Procedure: conventional surgery
Procedure: sentinel lymph node biopsy
Radiation: intraoperative radiation therapy
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Feasibility [ Designated as safety issue: No ]
- Reproducibility [ Designated as safety issue: No ]
- Quality of life (QLQ-C30) [ Designated as safety issue: No ]
- Satisfaction with care [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Cosmetic results [ Designated as safety issue: No ]
- Economic impact [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556777
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Jean-Bernard Dubois, MD||Centre Val d'Aurelle - Paul Lamarque|