Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
Official Title: Adjuvant Treatment of Non Small Cell Lung Cancer
Study ID: NCT00003053
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
George Papanicolaou General Hospital, Thessaloniki, , Greece
Ospedale Bassini, Balsamo Cinisello, , Italy
Universita Degli Studi di Bari Policlinico, Bari, , Italy
Spedali Civili, Brescia, , Italy
Ospedale Oncologico A. Businco, Cagliari, , Italy
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari, Cagliari, , Italy
Ospedale San Michele, Cagliari, , Italy
Ospedale Sant Anna, Como, , Italy
Ospedale Valduce, Como, , Italy
Ospedale Di Conselice, Conselice, , Italy
Ospedale Civile Cosenza, Cosenza, , Italy
Ospedale Maggiore Crema, Crema, , Italy
Ospedale Santa Croce, Cuneo, , Italy
Ospedale Civile Feltre, Feltre, , Italy
Universita di Ferrara, Ferrara, , Italy
Universita Degli Studi di Firenze - Policlin. di Careggi, Firenze (Florence), , Italy
Policlinico di Careggi, Firenze (Florence), , Italy
U.S.L. 10 Villa Ognissanti, Firenze, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), , Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate, Genoa (Genova), , Italy
Ospedale Galliera Oncologia, Genova (Genoa), , Italy
Ospedale Di Gorgonzola, Gorgonzola, , Italy
Ospedale Alessandro Manzoni, Lecco, , Italy
Ospedale Legnago USSL 21, Legnago, , Italy
Ospedale Maggiore Lodi, Lodi, , Italy
Ospedale Umberto I, Lugo DI Romagna, , Italy
U.S.S.L. 72 Magenta, Magenta, , Italy
Carlo Poma Hospital, Mantova, , Italy
Ospedale Di Predabissi Melegnano, Melegnano, , Italy
Azienda USSL NO 8, Merate, , Italy
Instituto Di Oncologia, Messina, , Italy
Ospedale Civile Umberto I, Mestre, , Italy
Ospedale San Carlo Borromeo, Milano (Milan), , Italy
Ospedale Luigi Sacco, Milano (Milan), , Italy
Ospedale Maggiore Ca'Granda, Milano (Milan), , Italy
Ospedale San Giuseppe, Milano, , Italy
Consorzio Provinciale Antitubercolare, Milano, , Italy
Istituto Scientifico H.San Raffaele, Milano, , Italy
Istituto Di Science Biomediche San Paolo, Milano, , Italy
Casa Di Cura San Ambrogio, Milano, , Italy
Ospedale Santa Croce, Moncalieri, , Italy
Nuovo Ospedale San Gerardo, Monza, , Italy
Ospedale Civile Asilo Vittoria, Mortara, , Italy
Federico II University Medical School, Naples (Napoli), , Italy
Istituto Tumori/Fondazione Pascale, Naples (Napoli), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy
Ospedale Vincenzo Monaldi, Napoli, , Italy
Ospedale C. Ascalesi, Napoli, , Italy
Ospedale Civile Negrar, Negrar, , Italy
Azienda Ospedaliera di Padova, Padova (Padua), , Italy
University of Padua, Padua, , Italy
Ospedale Civico E Benefratelli, Palermo, , Italy
Ospedale Maggiore Parma, Parma, , Italy
Ospedale Torrette University Ancona, Parma, , Italy
Ospedale Silvestrini, Perugia, , Italy
Ospedale Agnelli, Pinerolo, , Italy
Ospedale Sta. Maria Delle Croci, Ravenna, , Italy
Azienda Ospedaliera, Reggio Emilia, , Italy
Ospedale Civile Rho, Rho, , Italy
Istituti Fisioterapici Ospitalieri - Roma, Rome, , Italy
Ospedale San Filippo Neri, Rome, , Italy
Ospedale Carlo Forlanini, Rome, , Italy
Ospedale S. Camillo-Forlanini, Rome, , Italy
Azienda Policlinico Umberto Primo, Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy
Policlinico Militare Celio, Rome, , Italy
ASL NO. 1 Imperiese, San Remo, , Italy
Consorzio Mario Negri Sud, Santa Maria Imbaro, , Italy
Azienda USSL No 4, Saronno, , Italy
Istituto Clinica Medica, Sassari, , Italy
Ospedale Sesto San Giovanni, Sesto San Giovanni, , Italy
Azienda Ospedaliera S. Maria, Terni, , Italy
Ospedale Generale Prov. Boldrini, Thiene, , Italy
Dispensario Igiene Sociale, Toino, , Italy
Clinica Universita, Torino, , Italy
Universita di Torino, Torino, , Italy
Ospedale S. Chiara, Trento, , Italy
Ospedale San Isidoro, Trescore Balneario, , Italy
Ospedale General Regional Ca Foncello, Treviso, , Italy
Ospedale Maggiore dell' Universita, Trieste, , Italy
Ospedale Cattinara, Trieste, , Italy
Cattedra di Immunologia Clinica, Turin (TO), , Italy
Universita Degli Studi di Udine, Udine, , Italy
Casa di Cura S. Maria, Varese, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Inha University Hospital, Incheon, , Korea, Republic of
Contact Details
Name: Antonio Nicolucci, MD
Affiliation: Consorzio Mario Negri Sud
Role: STUDY_CHAIR
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