Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
NCT ID: NCT00003053
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
750 participants
INTERVENTIONAL
1994-01-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
etoposide
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Principal Investigators
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Antonio Nicolucci, MD
Role: STUDY_CHAIR
Consorzio Mario Negri Sud
Locations
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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
Florence, , 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 Giuseppe
Milan, , Italy
Consorzio Provinciale Antitubercolare
Milan, , Italy
Istituto Scientifico H.San Raffaele
Milan, , Italy
Istituto Di Science Biomediche San Paolo
Milan, , Italy
Casa Di Cura San Ambrogio
Milan, , Italy
Ospedale San Carlo Borromeo
Milano (Milan), , Italy
Ospedale Luigi Sacco
Milano (Milan), , Italy
Ospedale Maggiore Ca'Granda
Milano (Milan), , Italy
Ospedale Santa Croce
Moncalieri, , Italy
Nuovo Ospedale San Gerardo
Monza, , Italy
Ospedale Civile Asilo Vittoria
Mortara, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Federico II University Medical School
Naples (Napoli), , Italy
Istituto Tumori/Fondazione Pascale
Naples (Napoli), , 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
Sanremo, , 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, , South Korea
Countries
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Other Identifiers
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CNR-NICO-01
Identifier Type: -
Identifier Source: secondary_id
EU-97010
Identifier Type: -
Identifier Source: secondary_id
CDR0000065700
Identifier Type: -
Identifier Source: org_study_id