Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00002823
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns of failure, second malignancies, and toxic effects associated with each treatment regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, type of prior surgery, and pathologic stage. Each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center. The treatment group receives cisplatin combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4 courses, depending on the dose of cisplatin. The second group receives no adjuvant chemotherapy. Treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For patients in the treatment group, radiotherapy begins 3-4 weeks after the last course. Patients are followed at 6 months, then annually.
PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (123)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Ljubljana
🇸🇮Ljubljana, Slovenia
Evangelismos Hospital
🇬🇷Athens, Greece
Hopital Avicenne
🇫🇷Bobigny, France
C.H. Nord Mayenne
🇫🇷Mayenne, France
Institut Bergonie
🇫🇷Bordeaux, France
University Hospital of Heraklion
🇬🇷Iraklion (Heraklion), Crete, Greece
Athens University-Laikon General Hospital
🇬🇷Athens, Greece
Sismanoglio Hospital
🇬🇷Athens, Greece
Metaxa's Memorial Cancer Hospital
🇬🇷Piraeus, Greece
George Papanicolaou General Hospital
🇬🇷Thessaloniki, Greece
Sahlgrenska University Hospital
🇸🇪Gothenburg (Goteborg), Sweden
Ospedale Oncologico M. Ascoli
🇮🇹Palermo, Italy
Centre du Rouget
🇫🇷Sarcelles, France
Tel-Aviv Medical Center
🇮🇱Tel-Aviv, Israel
Park Lane Oncology Practice
🇿🇦Johannesburg, South Africa
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Centre Antoine Lacassagne
🇫🇷Nice, France
CHU De Pontchaillou
🇫🇷Rennes, France
University of Tromso
🇳🇴Tromso, Norway
Federico II University Medical School
🇮🇹Naples, Italy
Clinica Ars Medica
🇮🇹Rome, Italy
Centre de Radiologie et de Traitement des Tumeurs
🇫🇷Meudon-La-Foret, France
C.H.G. De Pau
🇫🇷Pau, France
Institute of Radiotherapy and Oncology
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Institut Mutualiste Montsouris
🇫🇷Paris, France
Institut Curie - Section Medicale
🇫🇷Paris, France
Sotiria Hospital Chest Diseases
🇬🇷Athens, Greece
Centre Hospitalier de Saint-Brieuc
🇫🇷Saint-Brieuc, France
Kaplan Hospital
🇮🇱Rehovot, Israel
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Centre Leon Berard
🇫🇷Lyon, France
Hospital Saint-Joseph
🇫🇷Paris, France
Hopital Jean Bernard
🇫🇷Poitiers, France
C.H. De Sens
🇫🇷Sens, France
C.H.G. Troyes
🇫🇷Troyes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopital Clinique Claude Bernard
🇫🇷Metz, France
National Kinki Central Hospital
🇯🇵Osaka, Japan
K. Dluski Hospital-Medical Academy
🇵🇱Wroclaw, Poland
Hospital Santa Maria
🇵🇹Lisbon (Lisboa), Portugal
Institute for Lung Diseases
Belgrade, Former Yugoslavia
Comprehensive Cancer Center at JFK Medical Center
🇺🇸Atlantis, Florida, United States
Getlac
🇦🇷Buenos Aires, Argentina
South Eastern Sydney Area Health Service
🇦🇺Randwick, New South Wales, Australia
AKH Vienna
🇦🇹Vienna, Austria
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Western Hospital
🇦🇺Melbourne, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
A.Z. St. Jan
🇧🇪Brugge, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Sint Elizabeth Ziekenhuis
🇧🇪Zottegem, Belgium
University of Clementino Fraga
🇧🇷Rio De Janeiro, Brazil
AZ Zusters Van Barmhartigheid
🇧🇪Ronse, Belgium
Porto Alegre Hospital
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Instituto Nacional de Cancer
🇧🇷Rio de Janeiro, Brazil
Instituto Nacional De Cancerologia
🇨🇴Bogota, Colombia
Hospital A.C. Camargo
🇧🇷Sao Paulo, Brazil
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Centre Hospital General Robert Ballanger
🇫🇷Aulnay Sous Bois, France
C.H.G. Beauvais
🇫🇷Beauvais, France
C.H. Armentieres
🇫🇷Armentieres, France
C.H. Henri Mondor
🇫🇷Aurillac, France
Clinique Hauts De Seine Bagneux
🇫🇷Bagneux, France
C.M.C. Du Cedre
🇫🇷Bois Guillaume (Rouen), France
CHU de Caen
🇫🇷Caen, France
Centre Du Meridien
🇫🇷Cannes, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Hopital Fontenoy
🇫🇷Chartres, France
Centre Hospitalier General
🇫🇷Compiegne, France
Hopital Antoine Beclere
🇫🇷Clamart, France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Hopital Intercommunal De Creteil
🇫🇷Creteil, France
Hopital D'Etampes
🇫🇷Etampes, France
C.H. De Grasse
🇫🇷Grasse, France
Centre Hospitalier de Lagny
🇫🇷Lagny, France
C.H.G. Du Havre-Hopital J. Monod
🇫🇷Le Havre, France
Centre Oscar Lambret
🇫🇷Lille, France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
🇫🇷Marseille, France
Hopital Tenon
🇫🇷Paris, France
Ospedale Cervello
🇮🇹Palermo, Italy
Ospedale San Filippo Neri
🇮🇹Rome, Italy
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
University of Patras Medical School
🇬🇷Rio Patras, Greece
Ospedale Civile Rimini
🇮🇹Rimini, Italy
Istituto Di Clinica Chirurgica
🇮🇹Torino, Italy
Universita Degli Studi di Udine
🇮🇹Udine, Italy
Ospedale Molinette
🇮🇹Turin, Italy
Ospedale Di Borgo Trento
🇮🇹Verona, Italy
Institut National D'Oncologie
🇲🇦Rabat, Morocco
Regional Hospital for Lung Disease
🇵🇱Zdunowo, Poland
Groote Schuur Hospital, Cape Town
🇿🇦Cape Town, South Africa
Institut Catala d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Sandton Oncology Centre
🇿🇦Johannesburg, South Africa
Hospital Arnau Vilanova
🇪🇸Valencia, Spain
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
University Hospital - Uppsala
🇸🇪Uppsala, Sweden
Karolinska Hospital
🇸🇪Stockholm, Sweden
Lund University Hospital
🇸🇪Lund, Sweden
University Hospital
🇨🇭Basel, Switzerland
Ratisches Kantons und Regionalspital
🇨🇭Chur, Switzerland
Kantonsspital, Luzern
🇨🇭Luzern (Lucerne), Switzerland
City Hospital Triemli
🇨🇭Zurich, Switzerland
Hopital Cantonal Universitaire de Geneva
🇨🇭Geneva, Switzerland
Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Universitaetsspital
🇨🇭Zurich, Switzerland
Hopital Universitaire F. Bourguiba
🇹🇳Monastir, Tunisia
Institute of Oncology
🇵🇱Lodz, Poland
Clinica Las Nieves
🇨🇱Santiago, Chile
Lung Centre of the Philippines
🇵🇭Quezon City Diliman, Philippines
Department of Children Hematology/Oncology University of Medicine Wroclaw
🇵🇱Wroclaw, Poland
Chest Disease Clinic, Charles University
🇨🇿Prague (Praha), Czech Republic
Lithuanian Oncology Center
🇱🇹Vilnius, Lithuania
Bialystok Medical School
🇵🇱Bialystok, Poland
Hospital Militar Central
🇨🇴Bogota, Colombia