Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer

NCT00002823 | Completed Phase 3

• 3 other identifiers: CDR0000065002FRE-IALTEU-96010
• Study Type: interventional
• Target: 3,300
• Locations: 27 countries
• Sites: 116

Brief Summary

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.

Conditions

Lung Cancer

Keywords

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

Interventions

cisplatin DRUG

etoposide DRUG

vinblastine sulfate DRUG

vindesine DRUG

vinorelbine tartrate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (123)

Comprehensive Cancer Center at JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Getlac

Buenos Aires, 1638, Argentina

Location

South Eastern Sydney Area Health Service

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Institute

East Melbourne, Victoria, 8006, Australia

Location

Western Hospital

Melbourne, Victoria, 3011, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

AKH Vienna

Vienna, A-1090, Austria

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

AZ Zusters Van Barmhartigheid

Ronse, B-9600, Belgium

Location

Sint Elizabeth Ziekenhuis

Zottegem, 9620, Belgium

Location

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Cep 2-0230, Brazil

Location

Porto Alegre Hospital

Porto Alegre, Rio Grande do Sul, 90035--003, Brazil

Location

Hospital A.C. Camargo

São Paulo, São Paulo, 01509--010, Brazil

Location

University of Clementino Fraga

Rio de Janeiro, Brazil

Location

Clinica Las Nieves

Santiago, Chile

Location

Hospital Militar Central

Bogotá, Colombia

Location

Instituto Nacional De Cancerologia

Bogotá, Colombia

Location

Chest Disease Clinic, Charles University

Prague (Praha), 162 00, Czechia

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institute for Lung Diseases

Belgrade, 11000, Federal Republic of Yugoslavia

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Centre Paul Papin

Angers, 49036, France

Location

C.H. Armentieres

Armentières, 59427, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

C.H. Henri Mondor

Aurillac, 15002, France

Location

Clinique Hauts De Seine Bagneux

Bagneux, 92220, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

C.M.C. Du Cedre

Bois Guillaume (Rouen), 76235, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Du Meridien

Cannes, 06400, France

Location

Hopital Fontenoy

Chartres, 28018, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Centre Hospitalier General

Compiègne, 60321, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

Hopital D'Etampes

Étampes, 91150, France

Location

C.H. De Grasse

Grasse, 06130, France

Location

Centre Hospitalier de Lagny

Lagny, 77405, France

Location

C.H.G. Du Havre-Hopital J. Monod

Le Havre, 76083, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Assistance Publique Hopitaux de Marseille Hopitaux Sud

Marseille, 13274, France

Location

C.H. Nord Mayenne

Mayenne, 53013, France

Location

Hopital Clinique Claude Bernard

Metz, 57070, France

Location

Centre de Radiologie et de Traitement des Tumeurs

Meudon-la-Forêt, 92360, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Mutualiste Montsouris

Paris, 75013, France

Location

Hospital Saint-Joseph

Paris, 75014, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Tenon

Paris, 75970, France

Location

C.H.G. De Pau

Pau, 64000, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

CHU De Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22023, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

C.H. De Sens

Sens, 89106, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

C.H.G. Troyes

Troyes, 10003, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

University Hospital of Heraklion

Iraklion (Heraklion), Crete, 71110, Greece

Location

Evangelismos Hospital

Athens, 10676, Greece

Location

Athens University-Laikon General Hospital

Athens, 11527, Greece

Location

Sismanoglio Hospital

Athens, 15126, Greece

Location

Sotiria Hospital Chest Diseases

Athens, Greece

Location

Metaxa's Memorial Cancer Hospital

Piraeus, 18537, Greece

Location

University of Patras Medical School

Rio Patras, GR-26500, Greece

Location

George Papanicolaou General Hospital

Thessaloniki, 57010, Greece

Location

Kaplan Hospital

Rehovot, 76100, Israel

Location

Tel-Aviv Medical Center

Tel Aviv, 62995, Israel

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Ospedale Cervello

Palermo, 90146, Italy

Location

Ospedale Oncologico M. Ascoli

Palermo, Italy

Location

Ospedale Civile Rimini

Rimini, 47037, Italy

Location

Ospedale San Filippo Neri

Rome, 00135, Italy

Location

Clinica Ars Medica

Rome, 00191, Italy

Location

Istituto Di Clinica Chirurgica

Torino, 10126, Italy

Location

Ospedale Molinette

Turin, 10126, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Ospedale Di Borgo Trento

Verona, 37126, Italy

Location

National Kinki Central Hospital

Osaka, 591, Japan

Location

Lithuanian Oncology Center

Vilnius, 2600, Lithuania

Location

Institut National D'Oncologie

Rabat, Morocco

Location

Institute of Radiotherapy and Oncology

Skopje, 91000, North Macedonia

Location

University of Tromso

Tromsø, N-9037, Norway

Location

Lung Centre of the Philippines

Quezon City Diliman, 1100, Philippines

Location

Bialystok Medical School

Bialystok, 15276, Poland

Location

Institute of Oncology

Lodz, 93509, Poland

Location

Department of Children Hematology/Oncology University of Medicine Wroclaw

Wroclaw, 50345, Poland

Location

K. Dluski Hospital-Medical Academy

Wroclaw, 53 439, Poland

Location

Regional Hospital for Lung Disease

Zdunowo, 20, Poland

Location

Hospital Santa Maria

Lisbon (Lisboa), 1699, Portugal

Location

University of Ljubljana

Ljubljana, 61105, Slovenia

Location

Groote Schuur Hospital, Cape Town

Cape Town, 7925, South Africa

Location

Sandton Oncology Centre

Johannesburg, 2121, South Africa

Location

Park Lane Oncology Practice

Johannesburg, South Africa

Location

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, 08907, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Arnau Vilanova

Valencia, 46015, Spain

Location

Sahlgrenska University Hospital

Gothenburg (Goteborg), S-413 45, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Lund University Hospital

Lund, S-22185, Sweden

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

University Hospital - Uppsala

Uppsala, S-751 85, Sweden

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Ratisches Kantons und Regionalspital

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Kantonsspital, Luzern

Luzern (Lucerne), CH-6000, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Hopital Universitaire F. Bourguiba

Monastir, 5000, Tunisia

Location

Related Publications (12)

• 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.

  PMID: 21471564 BACKGROUND

• 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.

  PMID: 16462183 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16870041 BACKGROUND

• 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.

  PMID: 21224045 RESULT

• 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.

  PMID: 19933916 RESULT

• 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.

  PMID: 20978195 RESULT

• 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.

  PMID: 17602078 RESULT

• 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.

  PMID: 16957145 RESULT

• 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.

  RESULT

• 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.

  PMID: 14736927 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Cisplatin; Etoposide; Vinblastine; Vindesine; Vinorelbine; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Thierry L. Le Chevalier, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 11, 2004
• Study Start: February 1, 1995
• Primary Completion: January 1, 2001
• Last Updated: March 28, 2013

Record last verified: 2011-04

Locations

AU (1); CH (7); TU (1); ES (3); US (2); CO (2); NO (1); BE (5); PH (1); SE (5); EG (1); PT (1); IT (11); MO (1); CZ (1); IL (2); BR (4); JP (1); LI (1); ZA (3); SL (1); GR (8); PL (5); CL (1); FR (45); FE (1); AR (1)