Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer (GERICO03)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00104702|
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : September 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2004|
|Primary Completion Date :||April 2008|
|Study Completion Date :||March 2011|
|Experimental: Concentrated and Focalized Radiotherapy||Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy|
- Reproducibility [ Time Frame: 1 month ]
- 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 ]
- Relapse-free survival [ Time Frame: 1 year ]
- Overall and specific survival [ Time Frame: 1 year ]
- Cosmetic result [ Time Frame: 1 year ]
- Direct and indirect costs [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|