Clinical trial NCT00003053: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 750
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: George Papanicolaou General Hospital
city: Balsamo Cinisello
country: Italy
facility: Ospedale Bassini
city: Bari
country: Italy
facility: Universita Degli Studi di Bari Policlinico
city: Brescia
country: Italy
facility: Spedali Civili
city: Cagliari
country: Italy
facility: Ospedale Oncologico A. Businco
city: Cagliari
country: Italy
facility: Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
city: Cagliari
country: Italy
facility: Ospedale San Michele
city: Como
country: Italy
facility: Ospedale Sant Anna
city: Como
country: Italy
facility: Ospedale Valduce
city: Conselice
country: Italy
facility: Ospedale Di Conselice
city: Cosenza
country: Italy
facility: Ospedale Civile Cosenza
city: Crema
country: Italy
facility: Ospedale Maggiore Crema
city: Cuneo
country: Italy
facility: Ospedale Santa Croce
city: Feltre
country: Italy
facility: Ospedale Civile Feltre
city: Ferrara
country: Italy
facility: Universita di Ferrara
city: Firenze (Florence)
country: Italy
facility: Universita Degli Studi di Firenze - Policlin. di Careggi
city: Firenze (Florence)
country: Italy
facility: Policlinico di Careggi
city: Firenze
country: Italy
facility: U.S.L. 10 Villa Ognissanti
city: Genoa (Genova)
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Genoa (Genova)
country: Italy
facility: Ospedale San Martino/Cliniche Universitarie Convenzionate
city: Genova (Genoa)
country: Italy
facility: Ospedale Galliera Oncologia
city: Gorgonzola
country: Italy
facility: Ospedale Di Gorgonzola
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Legnago
country: Italy
facility: Ospedale Legnago USSL 21
city: Lodi
country: Italy
facility: Ospedale Maggiore Lodi
city: Lugo DI Romagna
country: Italy
facility: Ospedale Umberto I
city: Magenta
country: Italy
facility: U.S.S.L. 72 Magenta
city: Mantova
country: Italy
facility: Carlo Poma Hospital
city: Melegnano
country: Italy
facility: Ospedale Di Predabissi Melegnano
city: Merate
country: Italy
facility: Azienda USSL NO 8
city: Messina
country: Italy
facility: Instituto Di Oncologia
city: Mestre
country: Italy
facility: Ospedale Civile Umberto I
city: Milano (Milan)
country: Italy
facility: Ospedale San Carlo Borromeo
city: Milano (Milan)
country: Italy
facility: Ospedale Luigi Sacco
city: Milano (Milan)
country: Italy
facility: Ospedale Maggiore Ca'Granda
city: Milano
country: Italy
facility: Ospedale San Giuseppe
city: Milano
country: Italy
facility: Consorzio Provinciale Antitubercolare
city: Milano
country: Italy
facility: Istituto Scientifico H.San Raffaele
city: Milano
country: Italy
facility: Istituto Di Science Biomediche San Paolo
city: Milano
country: Italy
facility: Casa Di Cura San Ambrogio
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
city: Monza
country: Italy
facility: Nuovo Ospedale San Gerardo
city: Mortara
country: Italy
facility: Ospedale Civile Asilo Vittoria
city: Naples (Napoli)
country: Italy
facility: Federico II University Medical School
city: Naples (Napoli)
country: Italy
facility: Istituto Tumori/Fondazione Pascale
city: Naples
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Napoli
country: Italy
facility: Ospedale Vincenzo Monaldi
city: Napoli
country: Italy
facility: Ospedale C. Ascalesi
city: Negrar
country: Italy
facility: Ospedale Civile Negrar
city: Padova (Padua)
country: Italy
facility: Azienda Ospedaliera di Padova
city: Padua
country: Italy
facility: University of Padua
city: Palermo
country: Italy
facility: Ospedale Civico E Benefratelli
city: Parma
country: Italy
facility: Ospedale Maggiore Parma
city: Parma
country: Italy
facility: Ospedale Torrette University Ancona
city: Perugia
country: Italy
facility: Ospedale Silvestrini
city: Pinerolo
country: Italy
facility: Ospedale Agnelli
city: Ravenna
country: Italy
facility: Ospedale Sta. Maria Delle Croci
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera
city: Rho
country: Italy
facility: Ospedale Civile Rho
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Roma
city: Rome
country: Italy
facility: Ospedale San Filippo Neri
city: Rome
country: Italy
facility: Ospedale Carlo Forlanini
city: Rome
country: Italy
facility: Ospedale S. Camillo-Forlanini
city: Rome
country: Italy
facility: Azienda Policlinico Umberto Primo
city: Rome
country: Italy
facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
city: Rome
country: Italy
facility: Policlinico Militare Celio
city: San Remo
country: Italy
facility: ASL NO. 1 Imperiese
city: Santa Maria Imbaro
country: Italy
facility: Consorzio Mario Negri Sud
city: Saronno
country: Italy
facility: Azienda USSL No 4
city: Sassari
country: Italy
facility: Istituto Clinica Medica
city: Sesto San Giovanni
country: Italy
facility: Ospedale Sesto San Giovanni
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Thiene
country: Italy
facility: Ospedale Generale Prov. Boldrini
city: Toino
country: Italy
facility: Dispensario Igiene Sociale
city: Torino
country: Italy
facility: Clinica Universita
city: Torino
country: Italy
facility: Universita di Torino
city: Trento
country: Italy
facility: Ospedale S. Chiara
city: Trescore Balneario
country: Italy
facility: Ospedale San Isidoro
city: Treviso
country: Italy
facility: Ospedale General Regional Ca Foncello
city: Trieste
country: Italy
facility: Ospedale Maggiore dell' Universita
city: Trieste
country: Italy
facility: Ospedale Cattinara
city: Turin (TO)
country: Italy
facility: Cattedra di Immunologia Clinica
city: Udine
country: Italy
facility: Universita Degli Studi di Udine
city: Varese
country: Italy
facility: Casa di Cura S. Maria
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Consorzio Mario Negri Sud
name: Antonio Nicolucci, MD
role: STUDY_CHAIR
References: