Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
NCT ID: NCT00002823
Last Updated: 2013-03-28
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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COMPLETED
PHASE3
3300 participants
INTERVENTIONAL
1995-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
etoposide
vinblastine sulfate
vindesine
vinorelbine tartrate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Thierry L. Le Chevalier, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Getlac
Buenos Aires, , Argentina
South Eastern Sydney Area Health Service
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia
Western Hospital
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
AKH Vienna
Vienna, , Austria
A.Z. St. Jan
Bruges, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
AZ Zusters Van Barmhartigheid
Ronse, , Belgium
Sint Elizabeth Ziekenhuis
Zottegem, , Belgium
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Hospital A.C. Camargo
São Paulo, São Paulo, Brazil
University of Clementino Fraga
Rio de Janeiro, , Brazil
Clinica Las Nieves
Santiago, , Chile
Hospital Militar Central
Bogotá, , Colombia
Instituto Nacional De Cancerologia
Bogotá, , Colombia
Chest Disease Clinic, Charles University
Prague (Praha), , Czechia
National Cancer Institute of Egypt
Cairo, , Egypt
Institute for Lung Diseases
Belgrade, , Federal Republic of Yugoslavia
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
Centre Paul Papin
Angers, , France
C.H. Armentieres
Armentières, , France
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , France
C.H. Henri Mondor
Aurillac, , France
Clinique Hauts De Seine Bagneux
Bagneux, , France
C.H.G. Beauvais
Beauvais, , France
Hopital Avicenne
Bobigny, , France
C.M.C. Du Cedre
Bois Guillaume (Rouen), , France
Institut Bergonie
Bordeaux, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Du Meridien
Cannes, , France
Hopital Fontenoy
Chartres, , France
Hopital Antoine Beclere
Clamart, , France
Centre Hospitalier General
Compiègne, , France
Hopital Intercommunal De Creteil
Créteil, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , France
Hopital D'Etampes
Étampes, , France
C.H. De Grasse
Grasse, , France
Centre Hospitalier de Lagny
Lagny, , France
C.H.G. Du Havre-Hopital J. Monod
Le Havre, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , France
C.H. Nord Mayenne
Mayenne, , France
Hopital Clinique Claude Bernard
Metz, , France
Centre de Radiologie et de Traitement des Tumeurs
Meudon-la-Forêt, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
Institut Mutualiste Montsouris
Paris, , France
Hospital Saint-Joseph
Paris, , France
Institut Curie - Section Medicale
Paris, , France
Hopital Tenon
Paris, , France
C.H.G. De Pau
Pau, , France
Hopital Jean Bernard
Poitiers, , France
CHU De Pontchaillou
Rennes, , France
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, , France
Centre du Rouget
Sarcelles, , France
C.H. De Sens
Sens, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
C.H.G. Troyes
Troyes, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
University Hospital of Heraklion
Iraklion (Heraklion), Crete, Greece
Evangelismos Hospital
Athens, , Greece
Athens University-Laikon General Hospital
Athens, , Greece
Sismanoglio Hospital
Athens, , Greece
Sotiria Hospital Chest Diseases
Athens, , Greece
Metaxa's Memorial Cancer Hospital
Piraeus, , Greece
University of Patras Medical School
Rio Patras, , Greece
George Papanicolaou General Hospital
Thessaloniki, , Greece
Kaplan Hospital
Rehovot, , Israel
Tel-Aviv Medical Center
Tel Aviv, , Israel
Istituto Europeo Di Oncologia
Milan, , Italy
Federico II University Medical School
Naples, , Italy
Ospedale Cervello
Palermo, , Italy
Ospedale Oncologico M. Ascoli
Palermo, , Italy
Ospedale Civile Rimini
Rimini, , Italy
Ospedale San Filippo Neri
Rome, , Italy
Clinica Ars Medica
Rome, , Italy
Istituto Di Clinica Chirurgica
Torino, , Italy
Ospedale Molinette
Turin, , Italy
Universita Degli Studi di Udine
Udine, , Italy
Ospedale Di Borgo Trento
Verona, , Italy
National Kinki Central Hospital
Osaka, , Japan
Lithuanian Oncology Center
Vilnius, , Lithuania
Institut National D'Oncologie
Rabat, , Morocco
Institute of Radiotherapy and Oncology
Skopje, , North Macedonia
University of Tromso
Tromsø, , Norway
Lung Centre of the Philippines
Quezon City Diliman, , Philippines
Bialystok Medical School
Bialystok, , Poland
Institute of Oncology
Lodz, , Poland
Department of Children Hematology/Oncology University of Medicine Wroclaw
Wroclaw, , Poland
K. Dluski Hospital-Medical Academy
Wroclaw, , Poland
Regional Hospital for Lung Disease
Zdunowo, , Poland
Hospital Santa Maria
Lisbon (Lisboa), , Portugal
University of Ljubljana
Ljubljana, , Slovenia
Groote Schuur Hospital, Cape Town
Cape Town, , South Africa
Sandton Oncology Centre
Johannesburg, , South Africa
Park Lane Oncology Practice
Johannesburg, , South Africa
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Hospital Arnau Vilanova
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg (Goteborg), , Sweden
University Hospital of Linkoping
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Karolinska Hospital
Stockholm, , Sweden
University Hospital - Uppsala
Uppsala, , Sweden
University Hospital
Basel, , Switzerland
Ospedale San Giovanni
Bellinzona, , Switzerland
Ratisches Kantons und Regionalspital
Chur, , Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , Switzerland
Kantonsspital, Luzern
Luzern (Lucerne), , Switzerland
City Hospital Triemli
Zurich, , Switzerland
Universitaetsspital
Zurich, , Switzerland
Hopital Universitaire F. Bourguiba
Monastir, , Tunisia
Countries
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References
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Reiman T, Lai R, Veillard AS, Paris E, Soria JC, Rosell R, Taron M, Graziano S, Kratzke R, Seymour L, Shepherd FA, Pignon JP, Seve P. Cross-validation study of class III beta-tubulin as a predictive marker for benefit from adjuvant chemotherapy in resected non-small-cell lung cancer: analysis of four randomized trials. Ann Oncol. 2012 Jan;23(1):86-93. doi: 10.1093/annonc/mdr033. Epub 2011 Apr 6.
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. doi: 10.1097/01.cco.0000208787.91947.a2.
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. doi: 10.3816/CLC.2006.n.028.
Bepler G, Olaussen KA, Vataire AL, Soria JC, Zheng Z, Dunant A, Pignon JP, Schell MJ, Fouret P, Pirker R, Filipits M, Brambilla E. ERCC1 and RRM1 in the international adjuvant lung trial by automated quantitative in situ analysis. Am J Pathol. 2011 Jan;178(1):69-78. doi: 10.1016/j.ajpath.2010.11.029. Epub 2010 Dec 23.
Arriagada R, Dunant A, Pignon JP, Bergman B, Chabowski M, Grunenwald D, Kozlowski M, Le Pechoux C, Pirker R, Pinel MI, Tarayre M, Le Chevalier T. Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol. 2010 Jan 1;28(1):35-42. doi: 10.1200/JCO.2009.23.2272. Epub 2009 Nov 23.
Voortman J, Goto A, Mendiboure J, Sohn JJ, Schetter AJ, Saito M, Dunant A, Pham TC, Petrini I, Lee A, Khan MA, Hainaut P, Pignon JP, Brambilla E, Popper HH, Filipits M, Harris CC, Giaccone G. MicroRNA expression and clinical outcomes in patients treated with adjuvant chemotherapy after complete resection of non-small cell lung carcinoma. Cancer Res. 2010 Nov 1;70(21):8288-98. doi: 10.1158/0008-5472.CAN-10-1348. Epub 2010 Oct 26.
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. doi: 10.1200/JCO.2006.08.2867.
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. doi: 10.1056/NEJMoa060570.
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. doi: 10.1056/NEJMoa031644.
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.
Other Identifiers
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FRE-IALT
Identifier Type: -
Identifier Source: secondary_id
EU-96010
Identifier Type: -
Identifier Source: secondary_id
CDR0000065002
Identifier Type: -
Identifier Source: org_study_id
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