Clinical trial NCT00002823: Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Official title: A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage III non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2004-03-11
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically documented non-small cell lung cancer Any non-small cell histology eligible Pathologic stage I/II/III disease that is completely resected with microscopically clear margins within 60 days of entry (30 days preferred)

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No clear contraindication to chemotherapy No second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: Complete resection required prior to entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: Comprehensive Cancer Center at JFK Medical Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Buenos Aires
country: Argentina
facility: Getlac
city: Randwick
country: Australia
facility: South Eastern Sydney Area Health Service
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Melbourne
country: Australia
facility: Western Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Vienna
country: Austria
facility: AKH Vienna
city: Brugge
country: Belgium
facility: A.Z. St. Jan
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Ronse
country: Belgium
facility: AZ Zusters Van Barmhartigheid
city: Zottegem
country: Belgium
facility: Sint Elizabeth Ziekenhuis
city: Porto Alegre
country: Brazil
facility: Porto Alegre Hospital
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Rio De Janeiro
country: Brazil
facility: University of Clementino Fraga
city: Sao Paulo
country: Brazil
facility: Hospital A.C. Camargo
city: Santiago
country: Chile
facility: Clinica Las Nieves
city: Bogota
country: Colombia
facility: Hospital Militar Central
city: Bogota
country: Colombia
facility: Instituto Nacional De Cancerologia
city: Prague (Praha)
country: Czech Republic
facility: Chest Disease Clinic, Charles University
city: Cairo
country: Egypt
facility: National Cancer Institute of Egypt
city: Belgrade
country: Former Yugoslavia
facility: Institute for Lung Diseases
city: Angers
country: France
facility: Centre Hospitalier Regional et Universitaire d'Angers
city: Angers
country: France
facility: Centre Paul Papin
city: Armentieres
country: France
facility: C.H. Armentieres
city: Aulnay Sous Bois
country: France
facility: Centre Hospital General Robert Ballanger
city: Aurillac
country: France
facility: C.H. Henri Mondor
city: Bagneux
country: France
facility: Clinique Hauts De Seine Bagneux
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bois Guillaume (Rouen)
country: France
facility: C.M.C. Du Cedre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Cannes
country: France
facility: Centre Du Meridien
city: Chartres
country: France
facility: Hopital Fontenoy
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Compiegne
country: France
facility: Centre Hospitalier General
city: Creteil
country: France
facility: Hopital Intercommunal De Creteil
city: Dijon
country: France
facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc
city: Etampes
country: France
facility: Hopital D'Etampes
city: Grasse
country: France
facility: C.H. De Grasse
city: Lagny
country: France
facility: Centre Hospitalier de Lagny
city: Le Havre
country: France
facility: C.H.G. Du Havre-Hopital J. Monod
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud
city: Mayenne
country: France
facility: C.H. Nord Mayenne
city: Metz
country: France
facility: Hopital Clinique Claude Bernard
city: Meudon-La-Foret
country: France
facility: Centre de Radiologie et de Traitement des Tumeurs
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Neuilly sur Seine
country: France
facility: Clinique Hartmann
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hospital Saint-Joseph
city: Paris
country: France
facility: Institut Curie - Section Medicale
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: C.H.G. De Pau
city: Poitiers
country: France
facility: Hopital Jean Bernard
city: Rennes
country: France
facility: CHU De Pontchaillou
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
city: Sarcelles
country: France
facility: Centre du Rouget
city: Sens
country: France
facility: C.H. De Sens
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
city: Troyes
country: France
facility: C.H.G. Troyes
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Iraklion (Heraklion)
country: Greece
facility: University Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Athens
country: Greece
facility: Athens University-Laikon General Hospital
city: Athens
country: Greece
facility: Sismanoglio Hospital
city: Athens
country: Greece
facility: Sotiria Hospital Chest Diseases
city: Piraeus
country: Greece
facility: Metaxa's Memorial Cancer Hospital
city: Rio Patras
country: Greece
facility: University of Patras Medical School
city: Thessaloniki
country: Greece
facility: George Papanicolaou General Hospital
city: Rehovot
country: Israel
facility: Kaplan Hospital
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Medical Center
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
city: Naples
country: Italy
facility: Federico II University Medical School
city: Palermo
country: Italy
facility: Ospedale Cervello
city: Palermo
country: Italy
facility: Ospedale Oncologico M. Ascoli
city: Rimini
country: Italy
facility: Ospedale Civile Rimini
city: Rome
country: Italy
facility: Ospedale San Filippo Neri
city: Rome
country: Italy
facility: Clinica Ars Medica
city: Torino
country: Italy
facility: Istituto Di Clinica Chirurgica
city: Turin
country: Italy
facility: Ospedale Molinette
city: Udine
country: Italy
facility: Universita Degli Studi di Udine
city: Verona
country: Italy
facility: Ospedale Di Borgo Trento
city: Osaka
country: Japan
facility: National Kinki Central Hospital
city: Vilnius
country: Lithuania
facility: Lithuanian Oncology Center
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Institute of Radiotherapy and Oncology
city: Rabat
country: Morocco
facility: Institut National D'Oncologie
city: Tromso
country: Norway
facility: University of Tromso
city: Quezon City Diliman
country: Philippines
facility: Lung Centre of the Philippines
city: Bialystok
country: Poland
facility: Bialystok Medical School
city: Lodz
country: Poland
facility: Institute of Oncology
city: Wroclaw
country: Poland
facility: Department of Children Hematology/Oncology University of Medicine Wroclaw
city: Wroclaw
country: Poland
facility: K. Dluski Hospital-Medical Academy
city: Zdunowo
country: Poland
facility: Regional Hospital for Lung Disease
city: Lisbon (Lisboa)
country: Portugal
facility: Hospital Santa Maria
city: Ljubljana
country: Slovenia
facility: University of Ljubljana
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, Cape Town
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
city: Johannesburg
country: South Africa
facility: Park Lane Oncology Practice
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia - Hospital Duran i Reynals
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Valencia
country: Spain
facility: Hospital Arnau Vilanova
city: Gothenburg (Goteborg)
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Uppsala
country: Sweden
facility: University Hospital - Uppsala
city: Basel
country: Switzerland
facility: University Hospital
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Chur
country: Switzerland
facility: Ratisches Kantons und Regionalspital
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneva
city: Luzern (Lucerne)
country: Switzerland
facility: Kantonsspital, Luzern
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Zurich
country: Switzerland
facility: Universitaetsspital
city: Monastir
country: Tunisia
facility: Hopital Universitaire F. Bourguiba
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Thierry L. Le Chevalier, MD
role: STUDY_CHAIR
References:
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