|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| Estimated Enrollment: | 3300 |
| Study Start Date: | February 1995 |
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 |
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
Hide Study 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 | |
| Study Chair: | Thierry L. Le Chevalier, MD | Institut Gustave Roussy |
More Information
| 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 |
|
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 |
|
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 |