NCT00556777

Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	axillary lymph node dissection
PROCEDURE	conventional surgery
PROCEDURE	sentinel lymph node biopsy
RADIATION	intraoperative radiation therapy

Timeline

• Start date: 2004-04-19
• Primary completion: 2008-12-31
• Completion: 2008-12-31
• First posted: 2007-11-12
• Last updated: 2025-03-06

Locations

1 site across 1 country: France