Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

NCT00003053 | Unknown Phase 3

• 3 other identifiers: CDR0000065700CNR-NICO-01EU-97010
• Study Type: interventional
• Target: 750
• Locations: 3 countries
• Sites: 86

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Interventions

cisplatin DRUG

etoposide DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (86)

George Papanicolaou General Hospital

Thessaloniki, 57010, Greece

Location

Ospedale Bassini

Balsamo Cinisello, 20092, Italy

Location

Universita Degli Studi di Bari Policlinico

Bari, 70124, Italy

Location

Spedali Civili

Brescia, 25124, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

Location

Cattedra di Oncologia Medica - Universita degli Studi di Cagliari

Cagliari, 09124, Italy

Location

Ospedale San Michele

Cagliari, 09134, Italy

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Valduce

Como, 22100, Italy

Location

Ospedale Di Conselice

Conselice, 48017, Italy

Location

Ospedale Civile Cosenza

Cosenza, 87100, Italy

Location

Ospedale Maggiore Crema

Crema, 26013, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Ospedale Civile Feltre

Feltre, 32100, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Universita Degli Studi di Firenze - Policlin. di Careggi

Firenze (Florence), 1 (50134), Italy

Location

Policlinico di Careggi

Firenze (Florence), 50134, Italy

Location

U.S.L. 10 Villa Ognissanti

Florence, 50139, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

Ospedale San Martino/Cliniche Universitarie Convenzionate

Genoa (Genova), 16132, Italy

Location

Ospedale Galliera Oncologia

Genova (Genoa), 16128, Italy

Location

Ospedale Di Gorgonzola

Gorgonzola, 20064, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Ospedale Legnago USSL 21

Legnago, 37045, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Ospedale Umberto I

Lugo DI Romagna, 48022, Italy

Location

U.S.S.L. 72 Magenta

Magenta, 20013, Italy

Location

Carlo Poma Hospital

Mantova, 46100, Italy

Location

Ospedale Di Predabissi Melegnano

Melegnano, 20077, Italy

Location

Azienda USSL NO 8

Merate, 22055, Italy

Location

Instituto Di Oncologia

Messina, 98122, Italy

Location

Ospedale Civile Umberto I

Mestre, 30174, Italy

Location

Ospedale San Giuseppe

Milan, 20100, Italy

Location

Consorzio Provinciale Antitubercolare

Milan, 20124, Italy

Location

Istituto Scientifico H.San Raffaele

Milan, 20132, Italy

Location

Istituto Di Science Biomediche San Paolo

Milan, 20142, Italy

Location

Casa Di Cura San Ambrogio

Milan, 20149, Italy

Location

Ospedale San Carlo Borromeo

Milano (Milan), 20153, Italy

Location

Ospedale Luigi Sacco

Milano (Milan), 20157, Italy

Location

Ospedale Maggiore Ca'Granda

Milano (Milan), 20162, Italy

Location

Ospedale Santa Croce

Moncalieri, 10024, Italy

Location

Nuovo Ospedale San Gerardo

Monza, 20052, Italy

Location

Ospedale Civile Asilo Vittoria

Mortara, 27036, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Federico II University Medical School

Naples (Napoli), 80131, Italy

Location

Istituto Tumori/Fondazione Pascale

Naples (Napoli), 80131, Italy

Location

Ospedale Vincenzo Monaldi

Napoli, 80131, Italy

Location

Ospedale C. Ascalesi

Napoli, 80139, Italy

Location

Ospedale Civile Negrar

Negrar, 37024, Italy

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

University of Padua

Padua, 35128, Italy

Location

Ospedale Civico E Benefratelli

Palermo, 90127, Italy

Location

Ospedale Maggiore Parma

Parma, 43100, Italy

Location

Ospedale Torrette University Ancona

Parma, 43100, Italy

Location

Ospedale Silvestrini

Perugia, 06132, Italy

Location

Ospedale Agnelli

Pinerolo, 10064, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Azienda Ospedaliera

Reggio Emilia, 42100, Italy

Location

Ospedale Civile Rho

Rho, 20017, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00128, Italy

Location

Ospedale San Filippo Neri

Rome, 00135, Italy

Location

Ospedale Carlo Forlanini

Rome, 00149, Italy

Location

Ospedale S. Camillo-Forlanini

Rome, 00152, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Policlinico Militare Celio

Rome, 00184, Italy

Location

ASL NO. 1 Imperiese

Sanremo, 18038, Italy

Location

Consorzio Mario Negri Sud

Santa Maria Imbaro, 66030, Italy

Location

Azienda USSL No 4

Saronno, 21047, Italy

Location

Istituto Clinica Medica

Sassari, 07100, Italy

Location

Ospedale Sesto San Giovanni

Sesto San Giovanni, 20099, Italy

Location

Azienda Ospedaliera S. Maria

Terni, 05100, Italy

Location

Ospedale Generale Prov. Boldrini

Thiene, 36016, Italy

Location

Dispensario Igiene Sociale

Toino, 10100, Italy

Location

Clinica Universita

Torino, 10126, Italy

Location

Universita di Torino

Torino, 10126, Italy

Location

Ospedale S. Chiara

Trento, 38100, Italy

Location

Ospedale San Isidoro

Trescore Balneario, 24069, Italy

Location

Ospedale General Regional Ca Foncello

Treviso, 31100, Italy

Location

Ospedale Maggiore dell' Universita

Trieste, 34100, Italy

Location

Ospedale Cattinara

Trieste, Italy

Location

Cattedra di Immunologia Clinica

Turin (TO), 10128, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Casa di Cura S. Maria

Varese, 21100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Etoposide; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Antonio Nicolucci, MD

  Consorzio Mario Negri Sud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1994
• Last Updated: September 20, 2013

Record last verified: 2008-01

Locations

IT (84); GR (1); KR (1)