NCT00104702

Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer

Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

Detailed description

OBJECTIVES: Primary * Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer. Secondary * Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients. * Determine relapse-free survival of patients treated with this regimen. * Determine overall and specific survival of patients treated with this regimen. * Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients. * Determine the direct and indirect costs of this regimen in these patients. OUTLINE: This is a multicenter, open-label, nonrandomized study. Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2004-07-01
• Primary completion: 2008-04-01
• Completion: 2011-03-01
• First posted: 2005-03-04
• Last updated: 2013-09-04

Locations

10 sites across 1 country: France