RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.

Condition	Treatment or Intervention	Phase
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer	Drug: cisplatin  Drug: etoposide  Procedure: adjuvant therapy  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer.

OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA).

Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician.

PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.

Ages Eligible for Study:  up to  70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery
• No evidence of lymphonodal enlargement during postsurgical chest CT scan

PATIENT CHARACTERISTICS: Age:

• 70 and under

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 times the upper limit of normal

Pulmonary:

• FEV1 at least 1 liter

Other:

• Less than 10% weight loss in the past 3 months
• No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Radical surgery required

Greece
      George Papanicolaou General Hospital, THESSALONIKI,  57010,  Greece
Italy
      ASL NO. 1 Imperiese, San Remo,  18038,  Italy
      Azienda Ospedaliera di Padova, Padova (Padua),  35128,  Italy
      Azienda Ospedaliera S. Maria, Terni,  05100,  Italy
      Azienda Ospedaliera, Reggio Emilia,  42100,  Italy
      Azienda Policlinico Umberto Primo, Rome,  00161,  Italy
      Azienda USSL No 4, Saronno,  21047,  Italy
      Azienda USSL NO 8, Merate,  22055,  Italy
      Carlo Poma Hospital, Mantova,  46100,  Italy
      Casa di Cura S. Maria, Varese,  21100,  Italy
      Casa Di Cura San Ambrogio, Milano,  20149,  Italy
      Cattedra di Immunologia Clinica, Turin (TO),  10128,  Italy
      Cattedra di Oncologia Medica - Universita degli Studi di Cagliari, Cagliari,  09124,  Italy
      Clinica Universita, Torino,  10126,  Italy
      Consorzio Mario Negri Sud, Santa Maria Imbaro,  66030,  Italy
      Consorzio Provinciale Antitubercolare, Milano,  20124,  Italy
      Dispensario Igiene Sociale, Toino,  10100,  Italy
      Federico II University Medical School, Naples (Napoli),  80131,  Italy
      Instituto Di Oncologia, Messina,  98122,  Italy
      Istituti Fisioterapici Ospitalieri - Roma, Rome,  00128,  Italy
      Istituto Clinica Medica, Sassari,  07100,  Italy
      Istituto Di Science Biomediche San Paolo, Milano,  20142,  Italy
      Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova),  16132,  Italy
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples,  80131,  Italy
      Istituto Scientifico H.San Raffaele, Milano,  20132,  Italy
      Istituto Tumori/Fondazione Pascale, Naples (Napoli),  80131,  Italy
      Nuovo Ospedale San Gerardo, Monza,  20052,  Italy
      Ospedale Agnelli, Pinerolo,  10064,  Italy
      Ospedale Alessandro Manzoni, Lecco,  23900,  Italy
      Ospedale Bassini, Balsamo Cinisello,  20092,  Italy
      Ospedale C. Ascalesi, Napoli,  80139,  Italy
      Ospedale Carlo Forlanini, Rome,  00149,  Italy
      Ospedale Cattinara, Trieste,  Italy
      Ospedale Civico E Benefratelli, Palermo,  90127,  Italy
      Ospedale Civile Asilo Vittoria, Mortara,  27036,  Italy
      Ospedale Civile Cosenza, Cosenza,  87100,  Italy
      Ospedale Civile Feltre, Feltre,  32100,  Italy
      Ospedale Civile Negrar, Negrar,  37024,  Italy
      Ospedale Civile Rho, Rho,  20017,  Italy
      Ospedale Civile Umberto I, Mestre,  30174,  Italy
      Ospedale Di Conselice, Conselice,  48017,  Italy
      Ospedale Di Gorgonzola, Gorgonzola,  20064,  Italy
      Ospedale Di Predabissi Melegnano, Melegnano,  20077,  Italy
      Ospedale Galliera Oncologia, Genova (Genoa),  16128,  Italy
      Ospedale General Regional Ca Foncello, Treviso,  31100,  Italy
      Ospedale Generale Prov. Boldrini, Thiene,  36016,  Italy
      Ospedale Legnago USSL 21, Legnago,  37045,  Italy
      Ospedale Luigi Sacco, Milano (Milan),  20157,  Italy
      Ospedale Maggiore Ca'Granda, Milano (Milan),  20162,  Italy
      Ospedale Maggiore Crema, Crema,  26013,  Italy
      Ospedale Maggiore dell' Universita, Trieste,  34100,  Italy
      Ospedale Maggiore Lodi, Lodi,  I-20075,  Italy
      Ospedale Maggiore Parma, Parma,  43100,  Italy
      Ospedale Oncologico A. Businco, Cagliari,  09121,  Italy
      Ospedale S. Camillo-Forlanini, Rome,  00152,  Italy
      Ospedale S. Chiara, Trento,  38100,  Italy
      Ospedale San Bortolo, Vicenza,  36100,  Italy
      Ospedale San Carlo Borromeo, Milano (Milan),  20153,  Italy
      Ospedale San Filippo Neri, Rome,  00135,  Italy
      Ospedale San Giuseppe, Milano,  20100,  Italy
      Ospedale San Isidoro, Trescore Balneario,  24069,  Italy
      Ospedale San Martino/Cliniche Universitarie Convenzionate, Genoa (Genova),  16132,  Italy
      Ospedale San Michele, Cagliari,  09134,  Italy
      Ospedale Sant Anna, Como,  22100,  Italy
      Ospedale Santa Croce, Moncalieri,  10024,  Italy
      Ospedale Santa Croce, Cuneo,  12100,  Italy
      Ospedale Sesto San Giovanni, Sesto San Giovanni,  20099,  Italy
      Ospedale Silvestrini, Perugia,  06132,  Italy
      Ospedale Sta. Maria Delle Croci, Ravenna,  48100,  Italy
      Ospedale Torrette University Ancona, Parma,  43100,  Italy
      Ospedale Umberto I, Lugo DI Romagna,  48022,  Italy
      Ospedale Valduce, Como,  22100,  Italy
      Ospedale Vincenzo Monaldi, Napoli,  80131,  Italy
      Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome,  00168,  Italy
      Policlinico di Careggi, Firenze (Florence),  50134,  Italy
      Policlinico Militare Celio, Rome,  00184,  Italy
      Spedali Civili, Brescia,  25124,  Italy
      U.S.L. 10 Villa Ognissanti, Firenze,  50139,  Italy
      U.S.S.L. 72 Magenta, Magenta,  20013,  Italy
      Universita Degli Studi di Bari Policlinico, Bari,  70124,  Italy
      Universita Degli Studi di Firenze - Policlin. di Careggi, Firenze (Florence),  1 (50134),  Italy
      Universita Degli Studi di Udine, Udine,  33100,  Italy
      Universita di Ferrara, Ferrara,  44100,  Italy
      Universita di Torino, Torino,  10126,  Italy
      University of Padua, Padua,  35128,  Italy
Korea, Republic of
      Inha University Hospital, Incheon,  Korea, Republic of

Study chairs or principal investigators

Antonio Nicolucci, MD,  Study Chair,  Consorzio Mario Negri Sud   

Study ID Numbers:  CDR0000065700; CNR-NICO-01; EU-97010
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003053
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08