A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT)
1 de septiembre de 2015 actualizado por: OSI Pharmaceuticals
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once.
Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses.
These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments.
Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up.
Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1252
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bad Berka, Alemania, 99437
- Zentralklinik Bad Berka
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Berlin, Alemania, 14165
- Helios Klinikum Emil von Behring GmbH
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Bochum, Alemania, 44791
- Augusta-Krankenanstalt Bochum
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Coswig, Alemania, 01640
- Fachkrankenhaus Coswig
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Essen, Alemania, 45122
- Universitaetsklinikum Essen
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Frankfurt/Main, Alemania, 60488
- Krankenhaus Nordwest
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Freiburg, Alemania, 79106
- Universitätsklinikum Freiburg
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Großhansdorf, Alemania, 22927
- LungenClinic Grosshansdorf
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Göttingen, Alemania, 37075
- Universitätsklinikum Göttingen
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Halle (Saale), Alemania, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
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Hamburg, Alemania, 21075
- Asklepios Klinik Harburg
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Heidelberg, Alemania, 69126
- Thoraxklinik Heidelberg
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Hemer, Alemania, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
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Karlsruhe, Alemania, 76137
- St. Vincentius-Kliniken Karlsruhe
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Lübeck, Alemania, 23538
- Universitaetsklinikum Schleswig-Holstein
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Mainz, Alemania, 55131
- Universitätsklinikum Mainz
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Muenchen-Gauting, Alemania, 82131
- Asklepios Klinikum Gauting
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Oldenburg, Alemania, 26121
- Pius Hospital Oldenburg
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Villingen-Schwenningen, Alemania, 78050
- Schwarzwald-Baar Klinikum
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Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1272AAA
- Hospital de Rehabilitación Respiratoria María Ferrer
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Mendoza, Argentina, M5500AYB
- COIR
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Rosario, Santa Fe, Argentina, S2001SBL
- Hospital Espanol de Rosario
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Santa Fé, Argentina, S3000FFU
- ISIS Centro Especializado De Luce S.A.
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Adelaide, Australia, 5067
- Respiratory Clinical Trials Pty., Ltd
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Ashford, Australia, SA 5037
- Ashford Cancer Centre
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Campbelltown Hospital
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Victoria
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East Bentleigh, Victoria, Australia, 3165
- Monash Medical Centre
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Fitzroy, Victoria, Australia, 3065
- St Vincent's Hospital Melbourne
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Innsbruck, Austria, 6020
- Universitaetsklinikum Innsbruck
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Linz, Austria, 4021
- Allgemeines Krankenhaus der Stadt Linz
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Salzburg, Austria, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
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Wien, Austria, 1130
- Krankenhaus Hietzing
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Wien, Austria, 1090
- Akh Wien
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Wien, Austria, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
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Wien, Austria, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
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Brussels, Bélgica, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Bélgica, 1070
- Hopital Erasme
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Charleroi, Bélgica, 6000
- Le Grand Hôpital de Charleroi
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La Louvière, Bélgica, 7100
- Centre Hospitalier Jolimont-Lobbes
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Toronto, Canadá, M6R 1B5
- St. Joseph's Health Centre
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Kingston, Ontario, Canadá, K7L 5P9
- Cancer Center of Southeastern Ontario at Kingston General Hospital
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Mississauga, Ontario, Canadá, L5M 2N1
- Trillium Health Partners - Credit Valley Hospital
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Newmarket, Ontario, Canadá, L3Y 2P9
- Stronach Regional cancer Centre at Southlake
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Oshawa, Ontario, Canadá, L1G 2B9
- RS MacLaughlin Durham Regional Cancer Centre
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Sault Ste Marie, Ontario, Canadá, P6A 5K7
- Sault Area Hospital
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Thunder Bay, Ontario, Canadá, P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital
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Quebec
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Montreal, Quebec, Canadá, H3A 1A1
- Royal Victoria Hospital
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canadá, H2W 1S6
- McGill Dept. of Oncology
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Gyeonggi-Do, Corea, república de, 442-723
- Saint Vincent's Hospital
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Incheon, Corea, república de, 405-760
- Gachon Medical School Ghil Medical Center
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Seoul, Corea, república de, 138-736
- Asan Medical Center
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Seoul, Corea, república de, 110-744
- Seoul National University Hospital
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Seoul, Corea, república de, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
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Madrid, España, 28041
- Hospital Universitario 12 de octubre
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Madrid, España, 28046
- Hospital Universitario La Paz
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Madrid, España, 28033
- Hospital Oncologico MD Anderson
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Málaga, España, 29010
- Hospital Carlos Haya
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Málaga, España, 29010
- Hospital Clínico Virgen de la Victoria
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Pamplona, España, 31008
- Clínica Universitaria de Navarra
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Santander, España, 39008
- Hospital Universitario Marqués de Valdecilla
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Sevilla, España, 41700
- Hospital Universitario de Valme
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Toledo, España, 45004
- Hospital Virgen de la Salud de Toledo
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Valencia, España, 46014
- Hospital General Universitario de Valencia
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Barcelona
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L' Hospitalet de Llobregat, Barcelona, España, 08907
- ICO (Institut Catalá d´Oncología)
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Manresa, Barcelona, España, 08243
- Fundacio Althaia
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Sabadell, Barcelona, España, 08208
- Corporació Sanitària Parc Taulí
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Madrid
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Majadahonda, Madrid, España, 28222
- Hospital Puerta de Hierro Majadahonda
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Science
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California
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Beverly Hills, California, Estados Unidos, 90211
- Tower Cancer Research Foundation
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Duarte, California, Estados Unidos, 91010
- City of Hope Nat'l Medical Center
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Medical Center
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90033
- USC/ Norris Comprehensive Cancer Center
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Newport Beach, California, Estados Unidos, 92658
- HOAG Memorial Hospital Presbyterian
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Palm Springs, California, Estados Unidos, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Pleasant Hill, California, Estados Unidos, 94523
- Bay Area Cancer Research Group, LLC
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San Francisco, California, Estados Unidos, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
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South Pasadena, California, Estados Unidos, 91030
- City of Hope Medical Group (COHMG)
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital
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Aurora, Colorado, Estados Unidos, 80012
- Rocky Mountain Cancer Center- Aurora
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Boulder, Colorado, Estados Unidos, 80303
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Estados Unidos, 80907
- Rocky Mountain Cancer Center
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Colorado Springs, Colorado, Estados Unidos, 80907
- Penrose St. Francis Health Services
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Colorado Springs, Colorado, Estados Unidos, 80909
- Rocky Mountain Cancer Center
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Denver, Colorado, Estados Unidos, 80218
- Rocky Mountain Cancer Center-Midtown
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Denver, Colorado, Estados Unidos, 80220
- Rocky Mountain Cancer Centers- Rose
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Lakewood, Colorado, Estados Unidos, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, Estados Unidos, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Estados Unidos, 80124
- Rocky Mountain Cancer Center-Sky Ridge
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Longmont, Colorado, Estados Unidos, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Estados Unidos, 80138
- Rocky Mountain Cancer Center-Parker
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Thornton, Colorado, Estados Unidos, 80260
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Sharon, Connecticut, Estados Unidos, 06069
- Smilow Cancer Hospital Care Center
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Stamford, Connecticut, Estados Unidos, 06902
- Hematology Oncology, P.C.
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Torrington, Connecticut, Estados Unidos, 06790
- Smilow Cancer Hospital Care Center
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Florida
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Hudson, Florida, Estados Unidos, 34667
- Florida Cancer Institute-New Hope
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Jacksonville, Florida, Estados Unidos, 32204
- Cancer Specialists of North Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Cancer Specialists of North Florida
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Lakeland, Florida, Estados Unidos, 33805
- Watson Clinic LLP
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Miami, Florida, Estados Unidos, 33176
- Advanced Medical Specialties
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New Port Richey, Florida, Estados Unidos, 34655
- Florida Cancer Institute- New Hope
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Orlando, Florida, Estados Unidos, 32806
- Florida Cancer Specialists
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Port St. Lucie, Florida, Estados Unidos, 34952
- Hematology Oncology Associates of the Treasure Coast
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Georgia
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Atlanta, Georgia, Estados Unidos, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
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Macon, Georgia, Estados Unidos, 31201
- Central Georgia Cancer Care, PC
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Georgia Oncology Centers, PC
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Mountain States Tumor Institute
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Meridian, Idaho, Estados Unidos, 83642
- Mountain States Tumor Institute
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Post Falls, Idaho, Estados Unidos, 83854
- Kootenai Cancer Center
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Twin Falls, Idaho, Estados Unidos, 83301
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago, Section of Hematology/Oncology
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology Hematology Assoc., LTD
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Indiana
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Carmel, Indiana, Estados Unidos, 46032
- Indiana University Health
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Fishers, Indiana, Estados Unidos, 46037
- Indiana University Health
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Greenfield, Indiana, Estados Unidos, 46140
- Indiana University Health
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Indianapolis, Indiana, Estados Unidos, 46219
- Indiana University Health
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Indianapolis, Indiana, Estados Unidos, 46227
- Indiana University Health
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Norton Healthcare, Inc.
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Louisiana
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Houma, Louisiana, Estados Unidos, 70363
- Leonard J. Chabert Medical Center
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Maine
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Brewer, Maine, Estados Unidos, 04412
- Cancer Care of Maine
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Maryland
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Baltimore, Maryland, Estados Unidos, 21204
- Greater Baltimore Medical Center
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Towson, Maryland, Estados Unidos, 21204
- St. Joseph Medical Center's Cancer Institute
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02135
- Caritas St. Elizabeth's Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- St. Joseph Mercy Hospital
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Minnesota
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Burnsville, Minnesota, Estados Unidos, 55337
- Minnesota Oncology Hematology, P.A.
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Edina, Minnesota, Estados Unidos, 55435-2150
- Minnesota Oncology Hematology, P.A.
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Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology, P.A.
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Minneapolis, Minnesota, Estados Unidos, 55404
- Minnesota Oncology Hematology, P.A.
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St. Paul, Minnesota, Estados Unidos, 55102-2389
- Minnesota Oncology Hematology
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology, P.A.
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
- Missouri Cancer Associates
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St. Joseph, Missouri, Estados Unidos, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- St. Francis Cancer Treatment Center
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Omaha, Nebraska, Estados Unidos, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, Estados Unidos, 89052
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
- Comprehensive Cancer Centers of Nevada
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New Hampshire
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Concord, New Hampshire, Estados Unidos, 03301
- NH Oncology-Hematology PA (Co)
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Hooksett, New Hampshire, Estados Unidos, 03106
- NH Oncology-Hematology PA
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico Health Science Center
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Santa Fe, New Mexico, Estados Unidos, 87505
- Christus St. Vincent Regional Cancer Center
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New York
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Brockport, New York, Estados Unidos, 14420
- Interlakes Oncology Hematology, PC
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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Canadaigua, New York, Estados Unidos, 14424
- Interlakes Oncology Hematology, PC
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Geneva, New York, Estados Unidos, 14456
- Interlakes Oncology Hematology, PC
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New Rochelle, New York, Estados Unidos, 10801
- Advanced Oncology Associates
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New York, New York, Estados Unidos, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
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Rochester, New York, Estados Unidos, 14623
- Interlakes Oncology Hematology, PC
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Rochester, New York, Estados Unidos, 14626
- Interlakes Oncology Hematology, PC
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Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Medical Center
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North Carolina
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Cary, North Carolina, Estados Unidos, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
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Hickory, North Carolina, Estados Unidos, 28602
- Carolina Oncology Specialists PA
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Raleigh, North Carolina, Estados Unidos, 27607
- Raleigh Hematology Oncology Associates
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Raleigh, North Carolina, Estados Unidos, 27609
- Raleigh Hematology Oncology Associates
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Ohio
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Canton, Ohio, Estados Unidos, 44710
- Aultman Hospital/ North Canton Medical Foundation
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Cleveland, Ohio, Estados Unidos, 44106
- University Hopsitals of Cleveland
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Columbus, Ohio, Estados Unidos, 43228
- Hematology Oncology Consultants Inc.
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Northwest Cancer Specialists, PC
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Portland, Oregon, Estados Unidos, 97225
- Northwest Cancer Specialists, PC
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Portland, Oregon, Estados Unidos, 97227
- Northwest Cancer Specialists, PC
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Portland, Oregon, Estados Unidos, 97213
- Earle A Chiles Research Institute
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Tualatin, Oregon, Estados Unidos, 97062
- Northwest Cancer Specialists, PC
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18015
- Cancer Care Associates - Medical Oncology
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Hospital of the University of Pennsylvania
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Pittsburg, Pennsylvania, Estados Unidos, 15212
- Allegheny General Hospital
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29210
- South Carolina Oncology Assoc., PA
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Easley, South Carolina, Estados Unidos, 29640
- Cancer Centers of the Carolinas
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Greenville, South Carolina, Estados Unidos, 29605
- Cancer Centers of the Carolinas
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Greenville, South Carolina, Estados Unidos, 29615
- Cancer Centers of the Carolinas
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Seneca, South Carolina, Estados Unidos, 29672
- Cancer Centers of the Carolinas, Seneca
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Spartanburg, South Carolina, Estados Unidos, 29307
- Cancer Centers of the Carolinas
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Tennessee
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Cookeville, Tennessee, Estados Unidos, 38501
- Cookeville Regional Medical Center
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Germantown, Tennessee, Estados Unidos, 38138
- Bostin Baskin Cancer Foundation
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Knoxville, Tennessee, Estados Unidos, 37909
- Tennessee Cancer Specialists
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Memphis, Tennessee, Estados Unidos, 38120
- West Clinic
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Memphis, Tennessee, Estados Unidos, 38119
- Family Cancer Center Foundation, Inc.
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Memphis, Tennessee, Estados Unidos, 38104
- Bostin Baskin Cancer Foundation
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Oncology, P.A. - Amarillo
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Beaumont, Texas, Estados Unidos, 77702-1449
- Texas Oncology Beaumont
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Dallas, Texas, Estados Unidos, 75246
- Baylor Charles A Sammons Cancer Center
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Dallas, Texas, Estados Unidos, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
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Flower Mound, Texas, Estados Unidos, 75028
- Texas Oncology - Flower Mound
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Fort Worth, Texas, Estados Unidos, 76132
- Texas Oncology Southwest Forth Worth
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Ft. Worth, Texas, Estados Unidos, 76104
- Texas Oncology, Fort Worth
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Garland, Texas, Estados Unidos, 75042-5788
- Texas Oncology, Garland
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New Braunfels, Texas, Estados Unidos, 78131
- Cancer Care Centers of South Texas - HOAST
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Paris, Texas, Estados Unidos, 75460-5004
- Texas Oncology - Paris
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Plano, Texas, Estados Unidos, 75075-7787
- Texas Oncology - Plano East
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San Antonio, Texas, Estados Unidos, 78229
- Cancer Care Centers of South Texas-HOAST
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Tyler, Texas, Estados Unidos, 75702
- Texas Oncology -Tyler
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Waco, Texas, Estados Unidos, 76712
- Texas Oncology Cancer Care and Research Center
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Virginia
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Christiansburg, Virginia, Estados Unidos, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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Christiansburg, Virginia, Estados Unidos, 24073
- Onc and Hem Associates of SW VA, Inc.
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Hampton, Virginia, Estados Unidos, 23666
- Virginia Oncology Associates
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Newport News, Virginia, Estados Unidos, 23606
- Virginia Oncology Associates
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Oncology Associates
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Roanoke, Virginia, Estados Unidos, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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Salem, Virginia, Estados Unidos, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
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Wytheville, Virginia, Estados Unidos, 24382
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
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Spokane, Washington, Estados Unidos, 99218
- Cancer Care Northwest-North
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Spokane, Washington, Estados Unidos, 99202
- Cancer Care Northwest
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Spokane Valley, Washington, Estados Unidos, 99216
- Cancer Care Northwest-Valley
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Vancouver, Washington, Estados Unidos, 98684
- Northwest Cancer Specialists, P.C.
-
Vancouver, Washington, Estados Unidos, 98686
- Northwest Cancer Specialist, P.C.
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Arkhangelsk, Federación Rusa, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
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Kemerovo, Federación Rusa, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
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Krasnodar, Federación Rusa, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
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Moscow, Federación Rusa, 105229
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
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Moscow, Federación Rusa, 115478
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
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Saint-Petersburg, Federación Rusa, 197022
- State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"
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Saint-Petersburg, Federación Rusa, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
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Saint-Petersburg, Federación Rusa, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
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Tomsk, Federación Rusa, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
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Yaroslavl, Federación Rusa, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
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Bayonne, Francia, 64100
- Centre d'oncologie et de radiothérapie du Pays Basque
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Brest cedex, Francia, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
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Caen Cedex, Francia, 14033
- CHU de Caen - Service de pneumologie
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Clermont-Ferrand cedex 1, Francia, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
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Lyon cedex 04, Francia, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
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Marseille cedex 9, Francia, 13273
- Institut Paoli-Calmettes
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PARIS cedex 14, Francia, 75014
- Fondation Hôpital Saint Joseph
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Paris, Francia, 75012
- Hôpital de Tenon
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Perpignan, Francia, 66000
- Centre Catalan d'Oncologie
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Rennes cedex 9, Francia, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
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Saint Priest en Jarez, Francia, 42271
- Institut de Cancerologie de La Loire
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Vandoeuvre-lès-Nancy Cedex, Francia, 54511
- Hôpital de Brabois
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Cedex 9
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Toulouse, Cedex 9, Francia, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
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Athens, Grecia, 15562
- IASO General Hospital of Athens
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Thessaloniki, Grecia, 54603
- "Papageorgiou" General Hospital of Thessaloniki
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Thessaloniki, Grecia, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
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Budapest, Hungría, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Budapest, Hungría, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
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Deszk, Hungría, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
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Pécs, Hungría, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
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Szekesfehervar, Hungría, 8000
- Fejer Megyei Szent Gyorgy Korhaz
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Szombathely, Hungría, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
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Ancona, Italia, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
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Bologna, Italia, 40139
- Ospedale Bellaria
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Catania, Italia, 95100
- Ospedale Garibaldi Nesima
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Genova, Italia, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
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Parma, Italia, 43100
- Azienda Ospedaliero- Universitaria di Parma
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Perugia, Italia, 06132
- Ospedale S. Maria Della Misericordia
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Roma, Italia, 00152
- Azienda Ospedaliera San Camillo Forlanini
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Lublin, Polonia, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Otwock, Polonia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Poznan, Polonia, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
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Szczecin, Polonia, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
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Warsaw, Polonia, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
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Wroclaw, Polonia, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
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Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Reino Unido, BS2 8ED
- Bristol Haematology and Oncology Centre
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Dundee, Reino Unido, DD1 9SY
- Ninewells Hospital
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Glasgow, Reino Unido, G12 0YN
- Beatson West of Scotland Cancer Centre
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Guildford, Reino Unido, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
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Lecester, Reino Unido, LE1 5WW
- Leicester Royal Infirmary
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Leeds, Reino Unido, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
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London, Reino Unido, SE1 9RT
- Guy's Hospital
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London, Reino Unido, SW3 6JJ
- Royal Marsden Hospital
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Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Ceske Budejovice, República Checa, 370 87
- Nemocnice Ceske Budejovice, a.s.
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Ostrava-Poruba, República Checa, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
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Praha, República Checa, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
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Bucuresti, Rumania, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
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Bucuresti, Rumania, 022328
- Institutul Oncologic Al. Trestioreanu
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Cluj-Napoca, Rumania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Iasi, Rumania, 700106
- Centrul de Oncologie Medicala
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Sibiu, Rumania, 550245
- Spitalul Clinic Judetean Sibiu
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Bihor
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Oradea, Bihor, Rumania, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
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Dolj
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Craiova, Dolj, Rumania, 200535
- Oncoloab SRL
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Changhua, Taiwán, 500-06
- Changhua Christian Hospital
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Kaohsiung, Taiwán, 833
- Chang Gung Medical Foundation
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Taichung, Taiwán, 404
- China Medical University Hospital
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Taichung, Taiwán, 402
- Chung Shan Medical University Hospital
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Taichung, Taiwán, 407
- Taichung Veterans General Hospital
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Taipei, Taiwán, 112
- Taipei Veterans General Hospital
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Taoyuan, Taiwán, 333
- Chang Gung Memorial Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests
- Patients may have up to 4 cycles of chemotherapy after surgery
- Complete removal of the tumor by surgery
Able to start drug under the following timelines:
- 6 months from the day of surgery for patients who get chemotherapy
- 3 months from the day of surgery for those who do not get chemotherapy
- Confirmed diagnosis of Stage IB-IIIA NSCLC
- Patients must be accessible for follow-up visits
Exclusion Criteria:
- History of prior radiotherapy for NSCLC either before or after surgery
- History of heart disease or uncontrolled heart arrhythmias within the previous year
- History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug
- History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
- Patients who have received chemotherapy for NSCLC before surgery
- Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Erlotinib
Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
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150 mg tablet
Otros nombres:
|
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Comparador de placebos: Placebo
Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
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Tableta de placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disease Free Survival (DFS)
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
|
DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator.
Participants without a DFS event were censored on the last adequate radiological assessment date.
|
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
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Disease Free Survival (DFS)
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).
|
DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator.
Participants without a DFS event were censored on the last adequate radiological assessment date.
|
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS)
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
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Overall survival was defined as the time from the date of randomization until the documented date of death.
Participants who were still alive were censored on the last day they were known to be alive.
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Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
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Overall Survival (OS)
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
|
Overall survival was defined as the time from the date of randomization until the documented date of death.
Participants who were still alive were censored on the last day they were known to be alive.
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Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
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Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
|
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator.
Participants without a DFS event were censored on the last adequate radiological assessment date.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
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Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
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Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
|
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator.
Participants without a DFS event were censored on the last adequate radiological assessment date.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
|
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
|
|
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)
|
Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. |
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)
|
|
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Periodo de tiempo: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)
|
Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. |
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)
|
|
Number of Participants With Adverse Events (AEs)
Periodo de tiempo: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.
|
An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List. A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug. |
From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2006
Finalización primaria (Actual)
1 de abril de 2013
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2006
Publicado por primera vez (Estimar)
8 de septiembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de septiembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2015
Última verificación
1 de septiembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- OSI-774-302
- 2005-001747-29 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de pulmón de células no pequeñas
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