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

Lung Cancer Clinical Trial

Official title:

Adjuvant Treatment of Non Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003053
• Other study ID #: CDR0000065700
• Secondary ID: CNR-NICO-01EU-97
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: January 1994

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• etoposide

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Greece	George Papanicolaou General Hospital	Thessaloniki
Italy	Ospedale Bassini	Balsamo Cinisello
Italy	Universita Degli Studi di Bari Policlinico	Bari
Italy	Spedali Civili	Brescia
Italy	Cattedra di Oncologia Medica - Universita degli Studi di Cagliari	Cagliari
Italy	Ospedale Oncologico A. Businco	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	U.S.L. 10 Villa Ognissanti	Firenze
Italy	Policlinico di Careggi	Firenze (Florence)
Italy	Universita Degli Studi di Firenze - Policlin. di Careggi	Firenze (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	Casa Di Cura San Ambrogio	Milano
Italy	Consorzio Provinciale Antitubercolare	Milano
Italy	Istituto Di Science Biomediche San Paolo	Milano
Italy	Istituto Scientifico H.San Raffaele	Milano
Italy	Ospedale San Giuseppe	Milano
Italy	Ospedale Luigi Sacco	Milano (Milan)
Italy	Ospedale Maggiore Ca'Granda	Milano (Milan)
Italy	Ospedale San Carlo Borromeo	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 C. Ascalesi	Napoli
Italy	Ospedale Vincenzo Monaldi	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	Azienda Policlinico Umberto Primo	Rome
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	Ospedale Carlo Forlanini	Rome
Italy	Ospedale S. Camillo-Forlanini	Rome
Italy	Ospedale San Filippo Neri	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 Cattinara	Trieste
Italy	Ospedale Maggiore dell' Universita	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
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Countries where clinical trial is conducted

Greece,  Italy,  Korea, Republic of,