|
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer  Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
For Condition: stage 3 non-small cell lung cancer,large cell lung cancer,stage 1 non-small cell lung cancer,adenosquamous cell lung cancer,squamous cell lung cancer,adenocarcinoma of the lung,stage 2 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Institut Gustave Roussy ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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) --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThierryChevalier, Study Chair, Institut Gustave Roussy
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, , 22023
France
Hopital Antoine Beclere
Clamart, , 92141
France
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
CHU De Pontchaillou
Rennes, , 35033
France
Kantonsspital, Luzern
Luzern (Lucerne), , CH-6000
Switzerland
Clinica Las Nieves
Santiago, ,
Chile
Ospedale Molinette
Turin, , 10126
Italy
Regional Hospital for Lung Disease
Zdunowo, , 20
Poland
C.H.G. De Pau
Pau, , 64000
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Hopital Tenon
Paris, , 75970
France
C.M.C. Du Cedre
Bois Guillaume (Rouen), , 76235
France
Department of Children Hematology/Oncology University of Medicine Wroclaw
Wroclaw, , 50345
Poland
C.H. Henri Mondor
Aurillac, , 15002
France
Bialystok Medical School
Bialystok, , 15276
Poland
Groote Schuur Hospital, Cape Town
Cape Town, , 7925
South Africa
Hospital Santa Maria
Lisbon (Lisboa), , 1699
Portugal
Istituto Europeo Di Oncologia
Milano, , 20141
Italy
Centre de Radiologie et de Traitement des Tumeurs
Meudon-La-Foret, , 92360
France
Hopital D'Etampes
Etampes, , 91150
France
Kaplan Hospital
Rehovot, , 76100
Israel
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , 08907
Spain
Istituto Di Clinica Chirurgica
Torino, , 10126
Italy
Hopital Universitaire F. Bourguiba
Monastir, , 5000
Tunisia
Centre Du Meridien
Cannes, , 06400
France
University Hospital - Uppsala
Uppsala, , S-751 85
Sweden
Sismanoglio Hospital
Athens, , 15126
Greece
Chest Disease Clinic, Charles University
Prague (Praha), , 162 00
Czech Republic
Centre Leon Berard
Lyon, , 69373
France
Hospital A.C. Camargo
Sao Paulo, , 01509--010
Brazil
Institute of Radiotherapy and Oncology
Skopje, , 91000
Macedonia, The Former Yugoslav Republic of
Hospital Militar Central
Bogota, ,
Colombia
Ospedale Cervello
Palermo, , 90146
Italy
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
C.H.G. Du Havre-Hopital J. Monod
Le Havre, , 76083
France
Centre Hospitalier General
Compiegne, , 60321
France
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
Hopital Intercommunal De Creteil
Creteil, , 94010
France
C.H. Armentieres
Armentieres, , 59427
France
Hopital Avicenne
Bobigny, , 93009
France
C.H.G. Troyes
Troyes, , 10003
France
Centre Hospitalier de Lagny
Lagny, , 77405
France
Tel-Aviv Medical Center
Tel Aviv, , 62995
Israel
C.H. Nord Mayenne
Mayenne, , 53013
France
Institut Mutualiste Montsouris
Paris, , 75013
France
Getlac
Buenos Aires, , 1638
Argentina
Athens University-Laikon General Hospital
Athens, , 11527
Greece
University Hospital of Heraklion
Iraklion (Heraklion), Crete, 71110
Greece
Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, 33462
United States
George Papanicolaou General Hospital
THESSALONIKI, , 57010
Greece
Centre Antoine Lacassagne
Nice, , 06189
France
C.H. De Grasse
Grasse, , 06130
France
Hospital Saint-Joseph
Paris, , 75014
France
Ospedale Di Borgo Trento
Verona, , 37126
Italy
University of Tromso
Tromso, , N-9037
Norway
Ospedale Oncologico M. Ascoli
Palermo, ,
Italy
Evangelismos Hospital
Athens, , 10676
Greece
University Hospital
Basel, , CH-4031
Switzerland
Universitaetsspital
Zurich, , CH-8091
Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
AKH Vienna
Vienna, , A-1090
Austria
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , 13274
France
Hopital Arnaud de Villeneuve
Montpellier, , 34295
France
Centre Oscar Lambret
Lille, , 59020
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Centre Paul Papin
Angers, , 49036
France
University of Patras Medical School
Rio Patras, , GR-26500
Greece
Lund University Hospital
Lund, , S-22185
Sweden
University of Clementino Fraga
Rio de Janeiro, ,
Brazil
Universita Degli Studi di Udine
Udine, , 33100
Italy
Hopitaux Universitaire de Strasbourg
Strasbourg, , 67091
France
Clinica Ars Medica
Rome, , 00191
Italy
Ratisches Kantons und Regionalspital
Chur, , CH-7000
Switzerland
Institut Curie - Section Medicale
Paris, , 75248
France
Alfred Hospital
Melbourne, Victoria, 3181
Australia
Sahlgrenska University Hospital
Gothenburg (Goteborg), , S-413 45
Sweden
Royal Melbourne Hospital
Parkville, Victoria, 3050
Australia
Institut National D'Oncologie
Rabat, ,
Morocco
South Eastern Sydney Area Health Service
Randwick, New South Wales, 2031
Australia
Clinique Hauts De Seine Bagneux
Bagneux, , 92220
France
Lithuanian Oncology Center
Vilnius, , 2600
Lithuania
Centre Regional Francois Baclesse
Caen, , 14076
France
Park Lane Oncology Practice
Johannesburg, ,
South Africa
Federico II University Medical School
Naples, , 80131
Italy
Sandton Oncology Centre
Johannesburg, , 2121
South Africa
A.Z. St. Jan
Brugge, , 8000
Belgium
Hospital Virgen de las Nieves
Granada, , 18014
Spain
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , 93602
France
Institute for Lung Diseases
Belgrade, , 11000
Yugoslavia
University of Ljubljana
LJUBLJANA, , 61105
Slovenia
Western Hospital
Melbourne, Victoria, 3011
Australia
Sint Elizabeth Ziekenhuis
Zottegem, , 9620
Belgium
Metaxa's Memorial Cancer Hospital
Piraeus, , 18537
Greece
Centre du Rouget
Sarcelles, , 95250
France
Hospital Arnau Vilanova
Valencia, , 46015
Spain
Hopital Clinique Claude Bernard
Metz, , 57070
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , 49033
France
CHU de Caen
Caen, , 14033
France
Instituto Nacional De Cancerologia
Bogota, ,
Colombia
National Kinki Central Hospital
Osaka, , 591
Japan
Clinique Hartmann
Neuilly-sur-Seine, , 92200
France
Institute of Oncology
Lodz, , 93509
Poland
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Australia
Hopital Jean Bernard
Poitiers, , 86021
France
National Cancer Institute of Egypt
Cairo, ,
Egypt
K. Dluski Hospital-Medical Academy
Wroclaw, , 53 439
Poland
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Sotiria Hospital Chest Diseases
Athens, ,
Greece
Ospedale Civile Rimini
Rimini, , 47037
Italy
AZ Zusters Van Barmhartigheid
Ronse, , B-9600
Belgium
C.H. De Sens
Sens, , 89106
France
University Hospital of Linkoping
Linkoping, , S-581 85
Sweden
Ospedale San Filippo Neri
Rome, , 00135
Italy
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, 90035--003
Brazil
Hopital Fontenoy
Chartres, , 28018
France
City Hospital Triemli
Zurich, , 8063
Switzerland
Instituto Nacional de Cancer
Rio de Janeiro, , Cep 2-0230
Brazil
C.H.G. Beauvais
Beauvais, , 60021
France
Institut Bergonie
Bordeaux, , 33076
France
Karolinska Hospital
Stockholm, , S-171 76
Sweden
Lung Centre of the Philippines
Quezon City Diliman, , 1100
Philippines
Additional Information:
Study ID Numbers: CDR0000065002; FRE-IALT,EU-96010
Study Start Date: February 1995
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002823
Other Stage 1 Non-Small Cell Lung Cancer Studies:
1. Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
2. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
3. Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
4. Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
5. EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
Related Studies:
Other stage 1 non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Wroclaw Clinical Trials
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
|
|
|
|
|
|
|
|
