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

September 19, 2013 updated by: European Institute of Oncology

Adjuvant Treatment of Non Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 57010
        • George Papanicolaou General Hospital
  • Italy
      • Balsamo Cinisello, Italy, 20092
        • Ospedale Bassini
      • Bari, Italy, 70124
        • Universita Degli Studi di Bari Policlinico
      • Brescia, Italy, 25124
        • Spedali Civili
      • Cagliari, Italy, 09121
        • Ospedale Oncologico A. Businco
      • Cagliari, Italy, 09124
        • Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
      • Cagliari, Italy, 09134
        • Ospedale San Michele
      • Como, Italy, 22100
        • Ospedale Valduce
      • Como, Italy, 22100
        • Ospedale Sant Anna
      • Conselice, Italy, 48017
        • Ospedale Di Conselice
      • Cosenza, Italy, 87100
        • Ospedale Civile Cosenza
      • Crema, Italy, 26013
        • Ospedale Maggiore Crema
      • Cuneo, Italy, 12100
        • Ospedale Santa Croce
      • Feltre, Italy, 32100
        • Ospedale Civile Feltre
      • Ferrara, Italy, 44100
        • Università di Ferrara
      • Firenze, Italy, 50139
        • U.S.L. 10 Villa Ognissanti
      • Firenze (Florence), Italy, 1 (50134)
        • Universita Degli Studi di Firenze - Policlin. di Careggi
      • Firenze (Florence), Italy, 50134
        • Policlinico di Careggi
      • Genoa (Genova), Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Genoa (Genova), Italy, 16132
        • Ospedale San Martino/Cliniche Universitarie Convenzionate
      • Genova (Genoa), Italy, 16128
        • Ospedale Galliera Oncologia
      • Gorgonzola, Italy, 20064
        • Ospedale Di Gorgonzola
      • Lecco, Italy, 23900
        • Ospedale Alessandro Manzoni
      • Legnago, Italy, 37045
        • Ospedale Legnago USSL 21
      • Lodi, Italy, I-20075
        • Ospedale Maggiore Lodi
      • Lugo DI Romagna, Italy, 48022
        • Ospedale Umberto I
      • Magenta, Italy, 20013
        • U.S.S.L. 72 Magenta
      • Mantova, Italy, 46100
        • Carlo Poma Hospital
      • Melegnano, Italy, 20077
        • Ospedale Di Predabissi Melegnano
      • Merate, Italy, 22055
        • Azienda USSL NO 8
      • Messina, Italy, 98122
        • Instituto Di Oncologia
      • Mestre, Italy, 30174
        • Ospedale Civile Umberto I
      • Milano, Italy, 20132
        • Istituto Scientifico H.San Raffaele
      • Milano, Italy, 20100
        • Ospedale San Giuseppe
      • Milano, Italy, 20124
        • Consorzio Provinciale Antitubercolare
      • Milano, Italy, 20142
        • Istituto Di Science Biomediche San Paolo
      • Milano, Italy, 20149
        • Casa Di Cura San Ambrogio
      • Milano (Milan), Italy, 20153
        • Ospedale San Carlo Borromeo
      • Milano (Milan), Italy, 20157
        • Ospedale Luigi Sacco
      • Milano (Milan), Italy, 20162
        • Ospedale Maggiore Ca'Granda
      • Moncalieri, Italy, 10024
        • Ospedale Santa Croce
      • Monza, Italy, 20052
        • Nuovo Ospedale San Gerardo
      • Mortara, Italy, 27036
        • Ospedale Civile Asilo Vittoria
      • Naples, Italy, 80131
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
      • Naples (Napoli), Italy, 80131
        • Federico II University Medical School
      • Naples (Napoli), Italy, 80131
        • Istituto Tumori/Fondazione Pascale
      • Napoli, Italy, 80131
        • Ospedale Vincenzo Monaldi
      • Napoli, Italy, 80139
        • Ospedale C. Ascalesi
      • Negrar, Italy, 37024
        • Ospedale Civile Negrar
      • Padova (Padua), Italy, 35128
        • Azienda Ospedaliera di Padova
      • Padua, Italy, 35128
        • University of Padua
      • Palermo, Italy, 90127
        • Ospedale Civico E Benefratelli
      • Parma, Italy, 43100
        • Ospedale Maggiore Parma
      • Parma, Italy, 43100
        • Ospedale Torrette University Ancona
      • Perugia, Italy, 06132
        • Ospedale Silvestrini
      • Pinerolo, Italy, 10064
        • Ospedale Agnelli
      • Ravenna, Italy, 48100
        • Ospedale Sta. Maria Delle Croci
      • Reggio Emilia, Italy, 42100
        • Azienda Ospedaliera
      • Rho, Italy, 20017
        • Ospedale Civile Rho
      • Rome, Italy, 00149
        • Ospedale Carlo Forlanini
      • Rome, Italy, 00152
        • Ospedale S. Camillo-Forlanini
      • Rome, Italy, 00161
        • Azienda Policlinico Umberto Primo
      • Rome, Italy, 00168
        • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
      • Rome, Italy, 00128
        • Istituti Fisioterapici Ospitalieri - Roma
      • Rome, Italy, 00135
        • Ospedale San Filippo Neri
      • Rome, Italy, 00184
        • Policlinico Militare Celio
      • San Remo, Italy, 18038
        • ASL NO. 1 Imperiese
      • Santa Maria Imbaro, Italy, 66030
        • Consorzio Mario Negri Sud
      • Saronno, Italy, 21047
        • Azienda USSL No 4
      • Sassari, Italy, 07100
        • Istituto Clinica Medica
      • Sesto San Giovanni, Italy, 20099
        • Ospedale Sesto San Giovanni
      • Terni, Italy, 05100
        • Azienda Ospedaliera S. Maria
      • Thiene, Italy, 36016
        • Ospedale Generale Prov. Boldrini
      • Toino, Italy, 10100
        • Dispensario Igiene Sociale
      • Torino, Italy, 10126
        • Università di Torino
      • Torino, Italy, 10126
        • Clinica Universita
      • Trento, Italy, 38100
        • Ospedale S. Chiara
      • Trescore Balneario, Italy, 24069
        • Ospedale San Isidoro
      • Treviso, Italy, 31100
        • Ospedale General Regional Ca Foncello
      • Trieste, Italy
        • Ospedale Cattinara
      • Trieste, Italy, 34100
        • Ospedale Maggiore dell' Universita
      • Turin (TO), Italy, 10128
        • Cattedra di Immunologia Clinica
      • Udine, Italy, 33100
        • Università degli Studi di Udine
      • Varese, Italy, 21100
        • Casa di Cura S. Maria
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo
  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Inha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065700
  • CNR-NICO-01
  • EU-97010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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