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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00556777
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study Start: 2004-04-19
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2008-12-31
• Study Completion: 2008-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy	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	During the treatment of irradiation (4 weeks)	reproducibility based on dosimetric criteria based on the Quality Index of the application.

Secondary Outcome Measures

Name	Time	Method
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	Impact described by th scores of "Activities of Daily Living scale"
Tolerability of partial irradiation of the breast by per-operative electron therapy	from the baseline to 12 months after the treatment	Tolerability done with Common Terminology Criteria for Adverse Events scale
Relapse-free survival	from the baseline to 12 months after the treatment	Relapse-free survival describes with radiologie evaluation
Disease-specific survival	from the baseline to 12 months after the treatment	Relapse-free survival describes with radiologie evaluation

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France