Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center at JFK Medical Center | Atlantis | Florida | United States | 33462 |
| 2 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 3 | Getlac | Buenos Aires | Argentina | 1638 | |
| 4 | South Eastern Sydney Area Health Service | Randwick | New South Wales | Australia | 2031 |
| 5 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 6 | Peter MacCallum Cancer Institute | East Melbourne | Victoria | Australia | 8006 |
| 7 | Western Hospital | Melbourne | Victoria | Australia | 3011 |
| 8 | Alfred Hospital | Melbourne | Victoria | Australia | 3181 |
| 9 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 10 | AKH Vienna | Vienna | Austria | A-1090 | |
| 11 | A.Z. St. Jan | Brugge | Belgium | 8000 | |
| 12 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | B-2650 | |
| 13 | U.Z. Gasthuisberg | Leuven | Belgium | B-3000 | |
| 14 | AZ Zusters Van Barmhartigheid | Ronse | Belgium | B-9600 | |
| 15 | Sint Elizabeth Ziekenhuis | Zottegem | Belgium | 9620 | |
| 16 | Porto Alegre Hospital | Porto Alegre | Rio Grande do Sul | Brazil | 90035--003 |
| 17 | Instituto Nacional de Cancer | Rio de Janeiro | Brazil | Cep 2-0230 | |
| 18 | University of Clementino Fraga | Rio De Janeiro | Brazil | ||
| 19 | Hospital A.C. Camargo | Sao Paulo | Brazil | 01509--010 | |
| 20 | Clinica Las Nieves | Santiago | Chile | ||
| 21 | Hospital Militar Central | Bogota | Colombia | ||
| 22 | Instituto Nacional De Cancerologia | Bogota | Colombia | ||
| 23 | Chest Disease Clinic, Charles University | Prague (Praha) | Czech Republic | 162 00 | |
| 24 | National Cancer Institute of Egypt | Cairo | Egypt | ||
| 25 | Institute for Lung Diseases | Belgrade | Former Yugoslavia | 11000 | |
| 26 | Centre Hospitalier Regional et Universitaire d'Angers | Angers | France | 49033 | |
| 27 | Centre Paul Papin | Angers | France | 49036 | |
| 28 | C.H. Armentieres | Armentieres | France | 59427 | |
| 29 | Centre Hospital General Robert Ballanger | Aulnay Sous Bois | France | 93602 | |
| 30 | C.H. Henri Mondor | Aurillac | France | 15002 | |
| 31 | Clinique Hauts De Seine Bagneux | Bagneux | France | 92220 | |
| 32 | C.H.G. Beauvais | Beauvais | France | 60021 | |
| 33 | Hopital Avicenne | Bobigny | France | 93009 | |
| 34 | C.M.C. Du Cedre | Bois Guillaume (Rouen) | France | 76235 | |
| 35 | Institut Bergonie | Bordeaux | France | 33076 | |
| 36 | CHU de Caen | Caen | France | 14033 | |
| 37 | Centre Regional Francois Baclesse | Caen | France | 14076 | |
| 38 | Centre Du Meridien | Cannes | France | 06400 | |
| 39 | Hopital Fontenoy | Chartres | France | 28018 | |
| 40 | Hopital Antoine Beclere | Clamart | France | 92141 | |
| 41 | Centre Hospitalier General | Compiegne | France | 60321 | |
| 42 | Hopital Intercommunal De Creteil | Creteil | France | 94010 | |
| 43 | Centre de Lute Contre le Cancer,Georges-Francois Leclerc | Dijon | France | 21079 | |
| 44 | Hopital D'Etampes | Etampes | France | 91150 | |
| 45 | C.H. De Grasse | Grasse | France | 06130 | |
| 46 | Centre Hospitalier de Lagny | Lagny | France | 77405 | |
| 47 | C.H.G. Du Havre-Hopital J. Monod | Le Havre | France | 76083 | |
| 48 | Centre Oscar Lambret | Lille | France | 59020 | |
| 49 | Centre Leon Berard | Lyon | France | 69373 | |
| 50 | Assistance Publique Hopitaux de Marseille Hopitaux Sud | Marseille | France | 13274 | |
| 51 | C.H. Nord Mayenne | Mayenne | France | 53013 | |
| 52 | Hopital Clinique Claude Bernard | Metz | France | 57070 | |
| 53 | Centre de Radiologie et de Traitement des Tumeurs | Meudon-La-Foret | France | 92360 | |
| 54 | Hopital Arnaud de Villeneuve | Montpellier | France | 34295 | |
| 55 | Clinique Hartmann | Neuilly sur Seine | France | 92200 | |
| 56 | Centre Antoine Lacassagne | Nice | France | 06189 | |
| 57 | Institut Mutualiste Montsouris | Paris | France | 75013 | |
| 58 | Hospital Saint-Joseph | Paris | France | 75014 | |
| 59 | Institut Curie - Section Medicale | Paris | France | 75248 | |
| 60 | Hopital Tenon | Paris | France | 75970 | |
| 61 | C.H.G. De Pau | Pau | France | 64000 | |
| 62 | Hopital Jean Bernard | Poitiers | France | 86021 | |
| 63 | CHU De Pontchaillou | Rennes | France | 35033 | |
| 64 | Centre Hospitalier de Saint-Brieuc | Saint-Brieuc | France | 22023 | |
| 65 | Centre du Rouget | Sarcelles | France | 95250 | |
| 66 | C.H. De Sens | Sens | France | 89106 | |
| 67 | Hopitaux Universitaire de Strasbourg | Strasbourg | France | 67091 | |
| 68 | C.H.G. Troyes | Troyes | France | 10003 | |
| 69 | Centre Alexis Vautrin | Vandoeuvre-les-Nancy | France | 54511 | |
| 70 | Institut Gustave Roussy | Villejuif | France | F-94805 | |
| 71 | University Hospital of Heraklion | Iraklion (Heraklion) | Crete | Greece | 71110 |
| 72 | Evangelismos Hospital | Athens | Greece | 10676 | |
| 73 | Athens University-Laikon General Hospital | Athens | Greece | 11527 | |
| 74 | Sismanoglio Hospital | Athens | Greece | 15126 | |
| 75 | Sotiria Hospital Chest Diseases | Athens | Greece | ||
| 76 | Metaxa's Memorial Cancer Hospital | Piraeus | Greece | 18537 | |
| 77 | University of Patras Medical School | Rio Patras | Greece | GR-26500 | |
| 78 | George Papanicolaou General Hospital | Thessaloniki | Greece | 57010 | |
| 79 | Kaplan Hospital | Rehovot | Israel | 76100 | |
| 80 | Tel-Aviv Medical Center | Tel-Aviv | Israel | 62995 | |
| 81 | Istituto Europeo Di Oncologia | Milano | Italy | 20141 | |
| 82 | Federico II University Medical School | Naples | Italy | 80131 | |
| 83 | Ospedale Cervello | Palermo | Italy | 90146 | |
| 84 | Ospedale Oncologico M. Ascoli | Palermo | Italy | ||
| 85 | Ospedale Civile Rimini | Rimini | Italy | 47037 | |
| 86 | Ospedale San Filippo Neri | Rome | Italy | 00135 | |
| 87 | Clinica Ars Medica | Rome | Italy | 00191 | |
| 88 | Istituto Di Clinica Chirurgica | Torino | Italy | 10126 | |
| 89 | Ospedale Molinette | Turin | Italy | 10126 | |
| 90 | Universita Degli Studi di Udine | Udine | Italy | 33100 | |
| 91 | Ospedale Di Borgo Trento | Verona | Italy | 37126 | |
| 92 | National Kinki Central Hospital | Osaka | Japan | 591 | |
| 93 | Lithuanian Oncology Center | Vilnius | Lithuania | 2600 | |
| 94 | Institute of Radiotherapy and Oncology | Skopje | Macedonia, The Former Yugoslav Republic of | 91000 | |
| 95 | Institut National D'Oncologie | Rabat | Morocco | ||
| 96 | University of Tromso | Tromso | Norway | N-9037 | |
| 97 | Lung Centre of the Philippines | Quezon City Diliman | Philippines | 1100 | |
| 98 | Bialystok Medical School | Bialystok | Poland | 15276 | |
| 99 | Institute of Oncology | Lodz | Poland | 93509 | |
| 100 | Department of Children Hematology/Oncology University of Medicine Wroclaw | Wroclaw | Poland | 50345 | |
| 101 | K. Dluski Hospital-Medical Academy | Wroclaw | Poland | 53 439 | |
| 102 | Regional Hospital for Lung Disease | Zdunowo | Poland | 20 | |
| 103 | Hospital Santa Maria | Lisbon (Lisboa) | Portugal | 1699 | |
| 104 | University of Ljubljana | Ljubljana | Slovenia | 61105 | |
| 105 | Groote Schuur Hospital, Cape Town | Cape Town | South Africa | 7925 | |
| 106 | Sandton Oncology Centre | Johannesburg | South Africa | 2121 | |
| 107 | Park Lane Oncology Practice | Johannesburg | South Africa | ||
| 108 | Institut Catala d'Oncologia - Hospital Duran i Reynals | Barcelona | Spain | 08907 | |
| 109 | Hospital Virgen de las Nieves | Granada | Spain | 18014 | |
| 110 | Hospital Arnau Vilanova | Valencia | Spain | 46015 | |
| 111 | Sahlgrenska University Hospital | Gothenburg (Goteborg) | Sweden | S-413 45 | |
| 112 | University Hospital of Linkoping | Linkoping | Sweden | S-581 85 | |
| 113 | Lund University Hospital | Lund | Sweden | S-22185 | |
| 114 | Karolinska Hospital | Stockholm | Sweden | S-171 76 | |
| 115 | University Hospital - Uppsala | Uppsala | Sweden | S-751 85 | |
| 116 | University Hospital | Basel | Switzerland | CH-4031 | |
| 117 | Ospedale San Giovanni | Bellinzona | Switzerland | CH-6500 | |
| 118 | Ratisches Kantons und Regionalspital | Chur | Switzerland | CH-7000 | |
| 119 | Hopital Cantonal Universitaire de Geneva | Geneva | Switzerland | CH-1211 | |
| 120 | Kantonsspital, Luzern | Luzern (Lucerne) | Switzerland | CH-6000 | |
| 121 | City Hospital Triemli | Zurich | Switzerland | 8063 | |
| 122 | Universitaetsspital | Zurich | Switzerland | CH-8091 | |
| 123 | Hopital Universitaire F. Bourguiba | Monastir | Tunisia | 5000 |
Sponsors and Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
Investigators
- Study Chair: Thierry L. Le Chevalier, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Reiman T, Lai R, Veillard AS, Paris E, Soria JC, Rosell R, Taron M, Graziano S, Kratzke R, Seymour L, Shepherd FA, Pignon JP, Sève 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.
- 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.
- CDR0000065002
- FRE-IALT
- EU-96010