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Trial record 21 of 24 for:    "Adenosquamous Lung Carcinoma" | "Antineoplastic Agents, Phytogenic"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002823
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: etoposide Drug: vinblastine sulfate Drug: vindesine Drug: vinorelbine tartrate Radiation: radiation therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : February 1995
Actual Primary Completion Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002823

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

Publications of Results:
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.
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 Publications:
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00002823     History of Changes
Other Study ID Numbers: CDR0000065002
First Posted: March 11, 2004    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: April 2011

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
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:
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Antineoplastic Agents, Phytogenic
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators