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.

Condition	Treatment or Intervention	Phase
stage III non-small cell lung cancer Adenosquamous Cell Lung Cancer stage II non-small cell lung cancer Squamous Cell Lung Cancer Adenocarcinoma of the Lung large cell lung cancer stage I non-small cell lung cancer	Drug: cisplatin  Drug: etoposide  Drug: vinblastine  Drug: vindesine  Drug: vinorelbine	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY 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)

--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

--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

Florida
      Comprehensive Cancer Center at JFK Medical Center, Atlantis,  Florida,  33462,  United States
Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Argentina
      Getlac, Buenos Aires,  1638,  Argentina
Australia, New South Wales
      South Eastern Sydney Area Health Service, Randwick,  New South Wales,  2031,  Australia
Australia, South Australia
      Royal Adelaide Hospital, Adelaide,  South Australia,  5000,  Australia
Australia, Victoria
      Alfred Hospital, Melbourne,  Victoria,  3181,  Australia
      Peter MacCallum Cancer Institute, East Melbourne,  Victoria,  8006,  Australia
      Royal Melbourne Hospital, Parkville,  Victoria,  3050,  Australia
      Western Hospital, Melbourne,  Victoria,  3011,  Australia
Austria
      AKH Vienna, Vienna,  A-1090,  Austria
Belgium
      A.Z. St. Jan, Brugge,  8000,  Belgium
      AZ Zusters Van Barmhartigheid, Ronse,  B-9600,  Belgium
      Sint Elizabeth Ziekenhuis, Zottegem,  9620,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium
Brazil
      University of Clementino Fraga, Rio de Janeiro,  Brazil
      Instituto Nacional de Cancer, Rio de Janeiro,  Cep 2-0230,  Brazil
      Hospital A.C. Camargo, Sao Paulo,  01509--010,  Brazil
Brazil, Rio Grande do Sul
      Porto Alegre Hospital, Porto Alegre,  Rio Grande do Sul,  90035--003,  Brazil
Chile
      Clinica Las Nieves, Santiago,  Chile
Colombia
      Hospital Militar Central, Bogota,  Colombia
      Instituto Nacional De Cancerologia, Bogota,  Colombia
Czech Republic
      Chest Disease Clinic, Charles University, Prague (Praha),  162 00,  Czech Republic
Egypt
      National Cancer Institute of Egypt, Cairo,  Egypt
France
      Assistance Publique Hopitaux de Marseille Hopitaux Sud, Marseille,  13274,  France
      C.H. Armentieres, Armentieres,  59427,  France
      C.H. De Grasse, Grasse,  06130,  France
      C.H. De Sens, Sens,  89106,  France
      C.H. Henri Mondor, Aurillac,  15002,  France
      C.H. Nord Mayenne, Mayenne,  53013,  France
      C.H.G. Beauvais, Beauvais,  60021,  France
      C.H.G. De Pau, Pau,  64000,  France
      C.H.G. Du Havre-Hopital J. Monod, Le Havre,  76083,  France
      C.H.G. Troyes, Troyes,  10003,  France
      C.M.C. Du Cedre, Bois Guillaume (Rouen),  76235,  France
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      Centre de Radiologie et de Traitement des Tumeurs, Meudon-La-Foret,  92360,  France
      Centre Du Meridien, Cannes,  06400,  France
      Centre du Rouget, Sarcelles,  95250,  France
      Centre Hospital General Robert Ballanger, Aulnay-sous-Bois,  93602,  France
      Centre Hospitalier de Lagny, Lagny,  77405,  France
      Centre Hospitalier de Saint-Brieuc, Saint-Brieuc,  22023,  France
      Centre Hospitalier General, Compiegne,  60321,  France
      Centre Hospitalier Regional et Universitaire d'Angers, Angers,  49033,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Oscar Lambret, Lille,  59020,  France
      Centre Paul Papin, Angers,  49036,  France
      Centre Regional Francois Baclesse, Caen,  14076,  France
      CHU de Caen, Caen,  14033,  France
      CHU De Pontchaillou, Rennes,  35033,  France
      Clinique Hartmann, Neuilly-sur-Seine,  92200,  France
      Clinique Hauts De Seine Bagneux, Bagneux,  92220,  France
      Hopital Antoine Beclere, Clamart,  92141,  France
      Hopital Arnaud de Villeneuve, Montpellier,  34295,  France
      Hopital Avicenne, Bobigny,  93009,  France
      Hopital Clinique Claude Bernard, Metz,  57070,  France
      Hopital D'Etampes, Etampes,  91150,  France
      Hopital Fontenoy, Chartres,  28018,  France
      Hopital Intercommunal De Creteil, Creteil,  94010,  France
      Hopital Jean Bernard, Poitiers,  86021,  France
      Hopital Tenon, Paris,  75970,  France
      Hopitaux Universitaire de Strasbourg, Strasbourg,  67091,  France
      Hospital Saint-Joseph, Paris,  75014,  France
      Institut Bergonie, Bordeaux,  33076,  France
      Institut Curie - Section Medicale, Paris,  75248,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
      Institut Mutualiste Montsouris, Paris,  75013,  France
Greece
      Athens University-Laikon General Hospital, Athens,  11527,  Greece
      Evangelismos Hospital, Athens,  10676,  Greece
      George Papanicolaou General Hospital, THESSALONIKI,  57010,  Greece
      Metaxa's Memorial Cancer Hospital, Piraeus,  18537,  Greece
      Sismanoglio Hospital, Athens,  15126,  Greece
      Sotiria Hospital Chest Diseases, Athens,  Greece
      University of Patras Medical School, Rio Patras,  GR-26500,  Greece
Greece, Crete
      University Hospital of Heraklion, Iraklion (Heraklion),  Crete,  71110,  Greece
Israel
      Kaplan Hospital, Rehovot,  76100,  Israel
      Tel-Aviv Medical Center, Tel Aviv,  62995,  Israel
Italy
      Clinica Ars Medica, Rome,  00191,  Italy
      Federico II University Medical School, Naples,  80131,  Italy
      Istituto Di Clinica Chirurgica, Torino,  10126,  Italy
      Istituto Europeo Di Oncologia, Milano,  20141,  Italy
      Ospedale Cervello, Palermo,  90146,  Italy
      Ospedale Civile Rimini, Rimini,  47037,  Italy
      Ospedale Di Borgo Trento, Verona,  37126,  Italy
      Ospedale Molinette, Turin,  10126,  Italy
      Ospedale Oncologico M. Ascoli, Palermo,  Italy
      Ospedale San Filippo Neri, Rome,  00135,  Italy
      Universita Degli Studi di Udine, Udine,  33100,  Italy
Japan
      National Kinki Central Hospital, Osaka,  591,  Japan
Lithuania
      Lithuanian Oncology Center, Vilnius,  2600,  Lithuania
Macedonia, The Former Yugoslav Republic of
      Institute of Radiotherapy and Oncology, Skopje,  91000,  Macedonia, The Former Yugoslav Republic of
Morocco
      Institut National D'Oncologie, Rabat,  Morocco
Norway
      University of Tromso, Tromso,  N-9037,  Norway
Philippines
      Lung Centre of the Philippines, Quezon City Diliman,  1100,  Philippines
Poland
      Bialystok Medical School, Bialystok,  15276,  Poland
      Department of Children Hematology/Oncology University of Medicine Wroclaw, Wroclaw,  50345,  Poland
      Institute of Oncology, Lodz,  93509,  Poland
      K. Dluski Hospital-Medical Academy, Wroclaw,  53 439,  Poland
      Regional Hospital for Lung Disease, Zdunowo,  20,  Poland
Portugal
      Hospital Santa Maria, Lisbon (Lisboa),  1699,  Portugal
Slovenia
      University of Ljubljana, LJUBLJANA,  61105,  Slovenia
South Africa
      Groote Schuur Hospital, Cape Town, Cape Town,  7925,  South Africa
      Park Lane Oncology Practice, Johannesburg,  South Africa
      Sandton Oncology Centre, Johannesburg,  2121,  South Africa
Spain
      Hospital Arnau Vilanova, Valencia,  46015,  Spain
      Hospital Virgen de las Nieves, Granada,  18014,  Spain
      Institut Catala d'Oncologia - Hospital Duran i Reynals, Barcelona,  08907,  Spain
Sweden
      Karolinska Hospital, Stockholm,  S-171 76,  Sweden
      Lund University Hospital, Lund,  S-22185,  Sweden
      Sahlgrenska University Hospital, Gothenburg (Goteborg),  S-413 45,  Sweden
      University Hospital - Uppsala, Uppsala,  S-751 85,  Sweden
      University Hospital of Linkoping, Linkoping,  S-581 85,  Sweden
Switzerland
      City Hospital Triemli, Zurich,  8063,  Switzerland
      Hopital Cantonal Universitaire de Geneva, Geneva,  CH-1211,  Switzerland
      Kantonsspital, Luzern, Luzern (Lucerne),  CH-6000,  Switzerland
      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland
      Ratisches Kantons und Regionalspital, Chur,  CH-7000,  Switzerland
      Universitaetsspital, Zurich,  CH-8091,  Switzerland
      University Hospital, Basel,  CH-4031,  Switzerland
Tunisia
      Hopital Universitaire F. Bourguiba, Monastir,  5000,  Tunisia
Yugoslavia
      Institute for Lung Diseases, Belgrade,  11000,  Yugoslavia

Study chairs or principal investigators

Thierry Le Chevalier,  Study Chair,  Institut Gustave Roussy   

Study ID Numbers:  CDR0000065002; FRE-IALT; EU-96010
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002823
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08