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Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Institut Gustave Roussy
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002823
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: vinblastine
Drug: vindesine
Drug: vinorelbine ditartrate
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 3300
Study Start Date: February 1995
Detailed Description:

OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns of failure, second malignancies, and toxic effects associated with each treatment regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, type of prior surgery, and pathologic stage. Each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center. The treatment group receives cisplatin combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4 courses, depending on the dose of cisplatin. The second group receives no adjuvant chemotherapy. Treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For patients in the treatment group, radiotherapy begins 3-4 weeks after the last course. Patients are followed at 6 months, then annually.

PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically documented non-small cell lung cancer Any non-small cell histology eligible Pathologic stage I/II/III disease that is completely resected with microscopically clear margins within 60 days of entry (30 days preferred)

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No clear contraindication to chemotherapy No second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: Complete resection required prior to entry

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002823

  Hide Study Locations
Locations
United States, Florida
Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, United States, 33462
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Argentina
Getlac
Buenos Aires, Argentina, 1638
Australia, New South Wales
South Eastern Sydney Area Health Service
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3181
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 8006
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Western Hospital
Melbourne, Victoria, Australia, 3011
Austria
AKH Vienna
Vienna, Austria, A-1090
Belgium
A.Z. St. Jan
Brugge, Belgium, 8000
AZ Zusters Van Barmhartigheid
Ronse, Belgium, B-9600
Sint Elizabeth Ziekenhuis
Zottegem, Belgium, 9620
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Brazil
University of Clementino Fraga
Rio De Janeiro, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, Cep 2-0230
Hospital A.C. Camargo
Sao Paulo, Brazil, 01509--010
Brazil, Rio Grande do Sul
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 90035--003
Chile
Clinica Las Nieves
Santiago, Chile
Colombia
Hospital Militar Central
Bogota, Colombia
Instituto Nacional De Cancerologia
Bogota, Colombia
Czech Republic
Chest Disease Clinic, Charles University
Prague (Praha), Czech Republic, 162 00
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
Former Yugoslavia
Institute for Lung Diseases
Belgrade, Former Yugoslavia, 11000
France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, France, 13274
C.H. Armentieres
Armentieres, France, 59427
C.H. De Grasse
Grasse, France, 06130
C.H. De Sens
Sens, France, 89106
C.H. Henri Mondor
Aurillac, France, 15002
Hopital Fontenoy
Chartres, France, 28018
C.H.G. Beauvais
Beauvais, France, 60021
C.H.G. De Pau
Pau, France, 64000
C.H.G. Du Havre-Hopital J. Monod
Le Havre, France, 76083
C.H.G. Troyes
Troyes, France, 10003
C.M.C. Du Cedre
Bois Guillaume (Rouen), France, 76235
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Centre Antoine Lacassagne
Nice, France, 06189
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre de Radiologie et de Traitement des Tumeurs
Meudon-La-Foret, France, 92360
Centre Du Meridien
Cannes, France, 06400
Centre du Rouget
Sarcelles, France, 95250
Centre Hospital General Robert Ballanger
Aulnay Sous Bois, France, 93602
Centre Hospitalier de Lagny
Lagny, France, 77405
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, France, 22023
Centre Hospitalier General
Compiegne, France, 60321
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
Centre Leon Berard
Lyon, France, 69373
Centre Oscar Lambret
Lille, France, 59020
Centre Paul Papin
Angers, France, 49036
Centre Regional Francois Baclesse
Caen, France, 14076
CHU de Caen
Caen, France, 14033
CHU De Pontchaillou
Rennes, France, 35033
Clinique Hartmann
Neuilly sur Seine, France, 92200
Clinique Hauts De Seine Bagneux
Bagneux, France, 92220
Hopital Antoine Beclere
Clamart, France, 92141
Hopital Arnaud de Villeneuve
Montpellier, France, 34295
Hopital Avicenne
Bobigny, France, 93009
Hopital Clinique Claude Bernard
Metz, France, 57070
Hopital D'Etampes
Etampes, France, 91150
C.H. Nord Mayenne
Mayenne, France, 53013
Hopital Intercommunal De Creteil
Creteil, France, 94010
Hopital Jean Bernard
Poitiers, France, 86021
Hopital Tenon
Paris, France, 75970
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, F-94805
Institut Bergonie
Bordeaux, France, 33076
Institut Curie - Section Medicale
Paris, France, 75248
Hospital Saint-Joseph
Paris, France, 75014
Institut Mutualiste Montsouris
Paris, France, 75013
Greece
Athens University-Laikon General Hospital
Athens, Greece, 11527
Evangelismos Hospital
Athens, Greece, 10676
George Papanicolaou General Hospital
Thessaloniki, Greece, 57010
University of Patras Medical School
Rio Patras, Greece, GR-26500
Sismanoglio Hospital
Athens, Greece, 15126
Sotiria Hospital Chest Diseases
Athens, Greece
Metaxa's Memorial Cancer Hospital
Piraeus, Greece, 18537
Greece, Crete
University Hospital of Heraklion
Iraklion (Heraklion), Crete, Greece, 71110
Israel
Kaplan Hospital
Rehovot, Israel, 76100
Tel-Aviv Medical Center
Tel-Aviv, Israel, 62995
Italy
Clinica Ars Medica
Rome, Italy, 00191
Ospedale Cervello
Palermo, Italy, 90146
Istituto Di Clinica Chirurgica
Torino, Italy, 10126
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Federico II University Medical School
Naples, Italy, 80131
Ospedale Civile Rimini
Rimini, Italy, 47037
Ospedale Di Borgo Trento
Verona, Italy, 37126
Ospedale Molinette
Turin, Italy, 10126
Ospedale Oncologico M. Ascoli
Palermo, Italy
Ospedale San Filippo Neri
Rome, Italy, 00135
Universita Degli Studi di Udine
Udine, Italy, 33100
Japan
National Kinki Central Hospital
Osaka, Japan, 591
Lithuania
Lithuanian Oncology Center
Vilnius, Lithuania, 2600
Macedonia, The Former Yugoslav Republic of
Institute of Radiotherapy and Oncology
Skopje, Macedonia, The Former Yugoslav Republic of, 91000
Morocco
Institut National D'Oncologie
Rabat, Morocco
Norway
University of Tromso
Tromso, Norway, N-9037
Philippines
Lung Centre of the Philippines
Quezon City Diliman, Philippines, 1100
Poland
Bialystok Medical School
Bialystok, Poland, 15276
Department of Children Hematology/Oncology University of Medicine Wroclaw
Wroclaw, Poland, 50345
Institute of Oncology
Lodz, Poland, 93509
K. Dluski Hospital-Medical Academy
Wroclaw, Poland, 53 439
Regional Hospital for Lung Disease
Zdunowo, Poland, 20
Portugal
Hospital Santa Maria
Lisbon (Lisboa), Portugal, 1699
Slovenia
University of Ljubljana
Ljubljana, Slovenia, 61105
South Africa
Groote Schuur Hospital, Cape Town
Cape Town, South Africa, 7925
Park Lane Oncology Practice
Johannesburg, South Africa
Sandton Oncology Centre
Johannesburg, South Africa, 2121
Spain
Hospital Arnau Vilanova
Valencia, Spain, 46015
Hospital Virgen de las Nieves
Granada, Spain, 18014
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain, 08907
Sweden
Karolinska Hospital
Stockholm, Sweden, S-171 76
Lund University Hospital
Lund, Sweden, S-22185
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
University Hospital - Uppsala
Uppsala, Sweden, S-751 85
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Switzerland
City Hospital Triemli
Zurich, Switzerland, 8063
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Kantonsspital, Luzern
Luzern (Lucerne), Switzerland, CH-6000
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
Universitaetsspital
Zurich, Switzerland, CH-8091
University Hospital
Basel, Switzerland, CH-4031
Tunisia
Hopital Universitaire F. Bourguiba
Monastir, Tunisia, 5000
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Study Chair: Thierry L. Le Chevalier, MD Institut Gustave Roussy
  More Information

Additional Information:
Publications:
Filipits M, Pirker R, Dunant A, Lantuejoul S, Schmid K, Huynh A, Haddad V, Andre F, Stahel R, Pignon JP, Soria JC, Popper HH, Le Chevalier T, Brambilla E. Cell cycle regulators and outcome of adjuvant cisplatin-based chemotherapy in completely resected non-small-cell lung cancer: the International Adjuvant Lung Cancer Trial Biologic Program. J Clin Oncol. 2007 Jul 1;25(19):2735-40.
Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91.
Brambilla E, Dunant A, Filipits M, et al.: Prognostic and predictive role of alterations of the P53-bax-bcl2 pathway of apoptosis in the IALT (International Adjuvant Lung Cancer Trial). [Abstract] Lung Cancer 50 (Suppl 2): A-O-021, S10, 2005.
Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60.
Le Chevalier T: Results of the Randomized International Adjuvant Lung Cancer Trial (IALT): cisplatin-based chemotherapy (CT) vs no CT in 1867 patients (pts) with resected non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-6, 2, 2003.
Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. Review.
Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.
Wakelee HA, Schiller JH, Gandara DR. Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer. 2006 Jul;8(1):18-21. Review.

Study ID Numbers: CDR0000065002, FRE-IALT, EU-96010
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002823     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage III non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vindesine
Vinblastine
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009