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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104702 |
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 | Intervention | Phase |
---|---|---|
Breast Cancer |
Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
Estimated Enrollment: | 42 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of invasive breast cancer
Stage I or II disease
Tumor size ≤ 30 mm
Hormone receptor status
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Didier Peiffert, MD 33-3-8359-8434 d.peiffert@nancy.fnclcc.fr | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06088 | |
Contact: J. M. Hannoun-Levi, MD 33-4-9203-1260 | |
Centre Hospitalier Lyon Sud | Recruiting |
Pierre Benite, France, 69495 | |
Contact: Pascale Romestaing, MD 33-4-78-86-42-51 pascale.romestaing@chu-lyon.fr | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Xavier Montbarbon 33-4-7234-5703 | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Yazid Belkacemi, MD, PhD 33-3-20-29-55-53 y-belkacemi@o-lambret.fr | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Hugo Marsiglia, MD 33-1-4211-4995 marsiglia@igr.fr | |
CHU Pitie-Salpetriere | Recruiting |
Paris, France, 75651 | |
Contact: Jean-Marc Simon 33-142-178-174 | |
Hopital Saint-Louis | Recruiting |
Paris, France, 75475 | |
Contact: Christophe Hennequin, PhD 33-1-4249-4949 christophe.hennequin@sls.ap-hop-paris.fr | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Laurence Thomas 33-5-5633-3333 | |
Centre Paul Strauss | Recruiting |
Strasbourg, France, 67065 | |
Contact: Philippe Quetin 33-3-8825-2478 |
Investigator: | J. M. Hannoun-Levi, MD | Centre Antoine Lacassagne |
Study ID Numbers: | CDR0000416123, FRE-FNCLCC-GERICO-03/0303, EU-20501 |
Study First Received: | March 3, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00104702 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer |
Skin Diseases Adjuvants, Immunologic Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |