Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer (GERICO03)
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.
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy|
- Reproducibility [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall and specific survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cosmetic result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Direct and indirect costs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Experimental: Concentrated and Focalized Radiotherapy||Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104702
|Bordeaux, France, 33076|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Centre Antoine Lacassagne|
|Nice, France, 06088|
|Paris, France, 75475|
|Paris, France, 75651|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Principal Investigator:||J. M. Hannoun-Levi, MD||Centre Antoine Lacassagne|