Spots Global Cancer Trial Database for Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Official Title: A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER
Study ID: NCT00002823
Conditions
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Brugge, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
AZ Zusters Van Barmhartigheid, Ronse, , Belgium
Sint Elizabeth Ziekenhuis, Zottegem, , Belgium
Porto Alegre Hospital, Porto Alegre, Rio Grande do Sul, Brazil
Instituto Nacional de Cancer, Rio de Janeiro, , Brazil
University of Clementino Fraga, Rio De Janeiro, , Brazil
Hospital A.C. Camargo, Sao Paulo, , Brazil
Clinica Las Nieves, Santiago, , Chile
Hospital Militar Central, Bogota, , Colombia
Instituto Nacional De Cancerologia, Bogota, , Colombia
Chest Disease Clinic, Charles University, Prague (Praha), , Czech Republic
National Cancer Institute of Egypt, Cairo, , Egypt
Institute for Lung Diseases, Belgrade, , Former Yugoslavia
Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France
Centre Paul Papin, Angers, , France
C.H. Armentieres, Armentieres, , 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, Compiegne, , France
Hopital Intercommunal De Creteil, Creteil, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon, , France
Hopital D'Etampes, Etampes, , 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-Foret, , 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, Vandoeuvre-les-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, Milano, , 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
Institute of Radiotherapy and Oncology, Skopje, , Macedonia, The Former Yugoslav Republic of
Institut National D'Oncologie, Rabat, , Morocco
University of Tromso, Tromso, , 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, Linkoping, , 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
Contact Details
Name: Thierry L. Le Chevalier, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
