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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: | NCT00410683 |
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Procedure: adjuvant therapy Procedure: observation Radiation: 3-dimensional conformal radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART] |
Estimated Enrollment: | 700 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | February 2021 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study.
Patients are stratified according to participating center, prior chemotherapy (neoadjuvant alone vs adjuvant vs none), number of lymph nodes involved (0 vs 1 vs ≥ 2), histology (squamous cell vs other), and use of pretreatment positron emission tomography scans (yes vs no). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Completely resected disease by lobectomy, bilobectomy, or pneumonectomy (absence of positive margins or extracapsular extension in a node removed separately)
PATIENT CHARACTERISTICS:
No severe cardiac disease within the past 6 months, including the following:
PRIOR CONCURRENT THERAPY:
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Veronique Beckendorf 33-3-8359-8425 | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Contact: Pierre-Yves Bondiau, MD, PhD 33-4-9203-1261 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Recruiting |
Dijon, France, 21079 | |
Contact: Karine Peignaux, MD 33-380-737-518 | |
Centre Eugene Marquis | Recruiting |
Rennes, France, 35042 | |
Contact: Mohamed Benchalal, MD 33-2-9925-3000 m.benchalal@rennes.fnclcc.fr | |
Centre Jean Perrin | Recruiting |
Clermont-Ferrand, France, 63011 | |
Contact: Pierre-Yves Verrelle 33-4-7327-8375 pierre.verrelle@cjp.fr | |
Centre Paul Papin | Recruiting |
Angers, France, 49036 | |
Contact: Claude Tuchais, MD 02-41-35-2884 c.tuchais@unimedan.fr | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Contact: Antoine Serre, MD 33-142-114-757 | |
Centre Regional Francois Baclesse | Recruiting |
Caen, France, 14076 | |
Contact: Delphine Lerouge, MD 33-2-3145-5020 d.lerouge@baclesse.fr | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Naji Salem, MD 33-4-9122-3637 | |
Hopital Avicenne | Recruiting |
Bobigny, France, 93009 | |
Contact: Jean F. Morere, MD 33-1-48-955-032 | |
Hopital Europeen Georges Pompidou | Recruiting |
Paris, France, 75015 | |
Contact: Catherine Maulard-Durdux, MD 33-1-56-09-3402 | |
Hopital Tenon | Recruiting |
Paris, France, 75970 | |
Contact: Armelle Lavole, MD 33-156-016-204 | |
Hopitaux de Brabois | Recruiting |
Vandoeuvre-Les-Nancy, France, 54511 | |
Contact: Yves Martinet, MD, PhD 33-3-83-15-34-80 y.martinet@chu-nancy.fr | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Philippe Giraud, MD 33-144-324-625 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Cecile Le Pechoux, MD 33-1-42-114-757 | |
Institut Sainte Catherine | Recruiting |
Avignon, France, 84000 | |
Contact: Nicolas Pourel, MD 33-490-27-60-31 | |
CHU de Caen | Recruiting |
Caen, France, 14033 | |
Contact: Gerard Zalcman, MD, PhD 33-231-06-46-77 |
Study Chair: | Cecile Le Pechoux, MD | Institut Gustave Roussy |
Study ID Numbers: | CDR0000523568, FRE-FNCLCC-PROTEGE-01/0601, EU-20671, IFCT-05-03, PAC POUMON |
Study First Received: | December 11, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00410683 History of Changes |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adjuvants, Immunologic |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |