Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
- Conditions
- Lung Cancer
- Registration Number
- NCT00003053
- Lead Sponsor
- European Institute of Oncology
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 750
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 (85)
Ospedale San Filippo Neri
🇮🇹Rome, Italy
Universita Degli Studi di Bari Policlinico
🇮🇹Bari, Italy
Ospedale Oncologico A. Businco
🇮🇹Cagliari, Italy
Ospedale Santa Croce
🇮🇹Moncalieri, Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
🇮🇹Firenze (Florence), Italy
Ospedale Galliera Oncologia
🇮🇹Genova (Genoa), Italy
Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Ospedale Maggiore Lodi
🇮🇹Lodi, Italy
Ospedale Umberto I
🇮🇹Lugo DI Romagna, Italy
Ospedale Di Predabissi Melegnano
🇮🇹Melegnano, Italy
Ospedale Vincenzo Monaldi
🇮🇹Napoli, Italy
Ospedale Civile Negrar
🇮🇹Negrar, Italy
University of Padua
🇮🇹Padua, Italy
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Clinica Universita
🇮🇹Torino, Italy
George Papanicolaou General Hospital
🇬🇷Thessaloniki, Greece
Ospedale Sant Anna
🇮🇹Como, Italy
Ospedale Bassini
🇮🇹Balsamo Cinisello, Italy
Ospedale Valduce
🇮🇹Como, Italy
Spedali Civili
🇮🇹Brescia, Italy
Ospedale San Michele
🇮🇹Cagliari, Italy
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
🇮🇹Cagliari, Italy
Ospedale Civile Cosenza
🇮🇹Cosenza, Italy
Ospedale Di Conselice
🇮🇹Conselice, Italy
Ospedale Maggiore Crema
🇮🇹Crema, Italy
Policlinico di Careggi
🇮🇹Firenze (Florence), Italy
Universita di Ferrara
🇮🇹Ferrara, Italy
Ospedale Civile Feltre
🇮🇹Feltre, Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate
🇮🇹Genoa (Genova), Italy
Ospedale Di Gorgonzola
🇮🇹Gorgonzola, Italy
U.S.L. 10 Villa Ognissanti
🇮🇹Firenze, Italy
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa (Genova), Italy
Ospedale Legnago USSL 21
🇮🇹Legnago, Italy
U.S.S.L. 72 Magenta
🇮🇹Magenta, Italy
Carlo Poma Hospital
🇮🇹Mantova, 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 Maggiore Ca'Granda
🇮🇹Milano (Milan), Italy
Ospedale Luigi Sacco
🇮🇹Milano (Milan), Italy
Ospedale San Giuseppe
🇮🇹Milano, Italy
Consorzio Provinciale Antitubercolare
🇮🇹Milano, Italy
Istituto Di Science Biomediche San Paolo
🇮🇹Milano, Italy
Casa Di Cura San Ambrogio
🇮🇹Milano, Italy
Istituto Scientifico H.San Raffaele
🇮🇹Milano, Italy
Nuovo Ospedale San Gerardo
🇮🇹Monza, Italy
Ospedale Civile Asilo Vittoria
🇮🇹Mortara, Italy
Federico II University Medical School
🇮🇹Naples (Napoli), Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Istituto Tumori/Fondazione Pascale
🇮🇹Naples (Napoli), Italy
Ospedale C. Ascalesi
🇮🇹Napoli, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova (Padua), Italy
Ospedale Civico E Benefratelli
🇮🇹Palermo, Italy
Ospedale Silvestrini
🇮🇹Perugia, Italy
Ospedale Maggiore Parma
🇮🇹Parma, Italy
Ospedale Agnelli
🇮🇹Pinerolo, Italy
Ospedale Torrette University Ancona
🇮🇹Parma, Italy
Ospedale Sta. Maria Delle Croci
🇮🇹Ravenna, Italy
Azienda Ospedaliera
🇮🇹Reggio Emilia, Italy
Ospedale Civile Rho
🇮🇹Rho, Italy
Ospedale Carlo Forlanini
🇮🇹Rome, Italy
Azienda Policlinico Umberto Primo
🇮🇹Rome, Italy
Ospedale S. Camillo-Forlanini
🇮🇹Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Policlinico Militare Celio
🇮🇹Rome, Italy
ASL NO. 1 Imperiese
🇮🇹San Remo, Italy
Ospedale Generale Prov. Boldrini
🇮🇹Thiene, Italy
Dispensario Igiene Sociale
🇮🇹Toino, Italy
Consorzio Mario Negri Sud
🇮🇹Santa Maria Imbaro, Italy
Azienda USSL No 4
🇮🇹Saronno, Italy
Azienda Ospedaliera S. Maria
🇮🇹Terni, Italy
Istituto Clinica Medica
🇮🇹Sassari, Italy
Ospedale Sesto San Giovanni
🇮🇹Sesto San Giovanni, Italy
Ospedale San Isidoro
🇮🇹Trescore Balneario, Italy
Universita di Torino
🇮🇹Torino, Italy
Ospedale S. Chiara
🇮🇹Trento, 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