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. september 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1252
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Australien, 5067
- Respiratory Clinical Trials Pty., Ltd
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Ashford, Australien, SA 5037
- Ashford Cancer Centre
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New South Wales
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Campbelltown, New South Wales, Australien, 2560
- Campbelltown Hospital
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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St Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital
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Victoria
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East Bentleigh, Victoria, Australien, 3165
- Monash Medical Centre
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Fitzroy, Victoria, Australien, 3065
- St Vincent's Hospital Melbourne
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Heidelberg, Victoria, Australien, 3084
- Austin Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Belgien, 1070
- Hôpital Erasme
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Charleroi, Belgien, 6000
- Le Grand Hôpital de Charleroi
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La Louvière, Belgien, 7100
- Centre Hospitalier Jolimont-Lobbes
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Toronto, Canada, M6R 1B5
- St. Joseph's Health Centre
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Center of Southeastern Ontario at Kingston General Hospital
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Mississauga, Ontario, Canada, L5M 2N1
- Trillium Health Partners - Credit Valley Hospital
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Newmarket, Ontario, Canada, L3Y 2P9
- Stronach Regional cancer Centre at Southlake
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Oshawa, Ontario, Canada, L1G 2B9
- RS MacLaughlin Durham Regional Cancer Centre
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Sault Ste Marie, Ontario, Canada, P6A 5K7
- Sault Area Hospital
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Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canada, H2W 1S6
- McGill Dept. of Oncology
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Arkhangelsk, Den Russiske Føderation, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
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Kemerovo, Den Russiske Føderation, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
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Krasnodar, Den Russiske Føderation, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
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Moscow, Den Russiske Føderation, 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, Den Russiske Føderation, 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, Den Russiske Føderation, 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, Den Russiske Føderation, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
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Saint-Petersburg, Den Russiske Føderation, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
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Tomsk, Den Russiske Føderation, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
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Yaroslavl, Den Russiske Føderation, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
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Birmingham, Det Forenede Kongerige, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Det Forenede Kongerige, BS2 8ED
- Bristol Haematology and Oncology centre
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Dundee, Det Forenede Kongerige, DD1 9SY
- Ninewells Hospital
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Glasgow, Det Forenede Kongerige, G12 0YN
- Beatson West of Scotland Cancer Centre
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Guildford, Det Forenede Kongerige, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
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Lecester, Det Forenede Kongerige, LE1 5WW
- Leicester Royal Infirmary
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Leeds, Det Forenede Kongerige, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
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London, Det Forenede Kongerige, SE1 9RT
- Guy's Hospital
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London, Det Forenede Kongerige, SW3 6JJ
- Royal Marsden Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
- Royal Marsden Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Science
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California
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Beverly Hills, California, Forenede Stater, 90211
- Tower Cancer Research Foundation
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Duarte, California, Forenede Stater, 91010
- City of Hope Nat'l Medical Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90033
- USC/ Norris Comprehensive Cancer Center
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Newport Beach, California, Forenede Stater, 92658
- Hoag Memorial Hospital Presbyterian
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Palm Springs, California, Forenede Stater, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Pleasant Hill, California, Forenede Stater, 94523
- Bay Area Cancer Research Group, LLC
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San Francisco, California, Forenede Stater, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
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South Pasadena, California, Forenede Stater, 91030
- City of Hope Medical Group (COHMG)
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Hospital
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Aurora, Colorado, Forenede Stater, 80012
- Rocky Mountain Cancer Center- Aurora
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Boulder, Colorado, Forenede Stater, 80303
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Center
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose St. Francis Health Services
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Colorado Springs, Colorado, Forenede Stater, 80909
- Rocky Mountain Cancer Center
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Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Cancer Center-Midtown
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Denver, Colorado, Forenede Stater, 80220
- Rocky Mountain Cancer Centers- Rose
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Lakewood, Colorado, Forenede Stater, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, Forenede Stater, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Forenede Stater, 80124
- Rocky Mountain Cancer Center-Sky Ridge
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Longmont, Colorado, Forenede Stater, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Forenede Stater, 80138
- Rocky Mountain Cancer Center-Parker
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Thornton, Colorado, Forenede Stater, 80260
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Sharon, Connecticut, Forenede Stater, 06069
- Smilow Cancer Hospital Care Center
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Stamford, Connecticut, Forenede Stater, 06902
- Hematology Oncology, P.C.
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Torrington, Connecticut, Forenede Stater, 06790
- Smilow Cancer Hospital Care Center
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Florida
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Hudson, Florida, Forenede Stater, 34667
- Florida Cancer Institute-New Hope
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Jacksonville, Florida, Forenede Stater, 32204
- Cancer Specialists of North Florida
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Jacksonville, Florida, Forenede Stater, 32216
- Cancer Specialists of North Florida
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Lakeland, Florida, Forenede Stater, 33805
- Watson Clinic LLP
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Miami, Florida, Forenede Stater, 33176
- Advanced Medical Specialties
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New Port Richey, Florida, Forenede Stater, 34655
- Florida Cancer Institute- New Hope
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Orlando, Florida, Forenede Stater, 32806
- Florida Cancer Specialists
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Port St. Lucie, Florida, Forenede Stater, 34952
- Hematology Oncology Associates of the Treasure Coast
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Georgia
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Atlanta, Georgia, Forenede Stater, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
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Macon, Georgia, Forenede Stater, 31201
- Central Georgia Cancer Care, PC
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Marietta, Georgia, Forenede Stater, 30060
- Northwest Georgia Oncology Centers, PC
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Mountain States Tumor Institute
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Meridian, Idaho, Forenede Stater, 83642
- Mountain States Tumor Institute
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Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Cancer Center
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Twin Falls, Idaho, Forenede Stater, 83301
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago, Section of Hematology/Oncology
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology Hematology Assoc., LTD
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Indiana University Health
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Fishers, Indiana, Forenede Stater, 46037
- Indiana University Health
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Greenfield, Indiana, Forenede Stater, 46140
- Indiana University Health
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Indianapolis, Indiana, Forenede Stater, 46219
- Indiana University Health
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Indianapolis, Indiana, Forenede Stater, 46227
- Indiana University Health
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Kansas
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Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Norton Healthcare, Inc.
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Louisiana
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Houma, Louisiana, Forenede Stater, 70363
- Leonard J. Chabert Medical Center
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Maine
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Brewer, Maine, Forenede Stater, 04412
- Cancer Care of Maine
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center
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Towson, Maryland, Forenede Stater, 21204
- St. Joseph Medical Center's Cancer Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02135
- Caritas St. Elizabeth's Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- St. Joseph Mercy Hospital
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Minnesota Oncology Hematology, P.A.
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Edina, Minnesota, Forenede Stater, 55435-2150
- Minnesota Oncology Hematology, P.A.
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, P.A.
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Minneapolis, Minnesota, Forenede Stater, 55404
- Minnesota Oncology Hematology, P.A.
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St. Paul, Minnesota, Forenede Stater, 55102-2389
- Minnesota Oncology Hematology
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, P.A.
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Missouri Cancer Associates
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St. Joseph, Missouri, Forenede Stater, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- St. Francis Cancer Treatment Center
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Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, Forenede Stater, 89052
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Forenede Stater, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Forenede Stater, 89169
- Comprehensive Cancer Centers of Nevada
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New Hampshire
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Concord, New Hampshire, Forenede Stater, 03301
- NH Oncology-Hematology PA (Co)
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Hooksett, New Hampshire, Forenede Stater, 03106
- NH Oncology-Hematology PA
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Health Science Center
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Santa Fe, New Mexico, Forenede Stater, 87505
- Christus St. Vincent Regional Cancer Center
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New York
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Brockport, New York, Forenede Stater, 14420
- Interlakes Oncology Hematology, PC
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Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
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Canadaigua, New York, Forenede Stater, 14424
- Interlakes Oncology Hematology, PC
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Geneva, New York, Forenede Stater, 14456
- Interlakes Oncology Hematology, PC
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New Rochelle, New York, Forenede Stater, 10801
- Advanced Oncology Associates
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New York, New York, Forenede Stater, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
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Rochester, New York, Forenede Stater, 14623
- Interlakes Oncology Hematology, PC
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Rochester, New York, Forenede Stater, 14626
- Interlakes Oncology Hematology, PC
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Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Medical Center
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North Carolina
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Cary, North Carolina, Forenede Stater, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
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Hickory, North Carolina, Forenede Stater, 28602
- Carolina Oncology Specialists PA
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Raleigh, North Carolina, Forenede Stater, 27607
- Raleigh Hematology Oncology Associates
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Raleigh, North Carolina, Forenede Stater, 27609
- Raleigh Hematology Oncology Associates
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Ohio
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Canton, Ohio, Forenede Stater, 44710
- Aultman Hospital/ North Canton Medical Foundation
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Cleveland, Ohio, Forenede Stater, 44106
- University Hopsitals of Cleveland
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Columbus, Ohio, Forenede Stater, 43228
- Hematology Oncology Consultants Inc.
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Northwest Cancer Specialists, PC
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Portland, Oregon, Forenede Stater, 97225
- Northwest Cancer Specialists, PC
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Portland, Oregon, Forenede Stater, 97227
- Northwest Cancer Specialists, PC
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Portland, Oregon, Forenede Stater, 97213
- Earle A Chiles Research Institute
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Tualatin, Oregon, Forenede Stater, 97062
- Northwest Cancer Specialists, PC
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- Cancer Care Associates - Medical Oncology
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- The Hospital of the University of Pennsylvania
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Pittsburg, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29210
- South Carolina Oncology Assoc., PA
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Easley, South Carolina, Forenede Stater, 29640
- Cancer Centers of the Carolinas
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Greenville, South Carolina, Forenede Stater, 29605
- Cancer Centers of the Carolinas
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Greenville, South Carolina, Forenede Stater, 29615
- Cancer Centers of the Carolinas
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Seneca, South Carolina, Forenede Stater, 29672
- Cancer Centers of the Carolinas, Seneca
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Spartanburg, South Carolina, Forenede Stater, 29307
- Cancer Centers of the Carolinas
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Tennessee
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Cookeville, Tennessee, Forenede Stater, 38501
- Cookeville Regional Medical Center
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Germantown, Tennessee, Forenede Stater, 38138
- Bostin Baskin Cancer Foundation
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Knoxville, Tennessee, Forenede Stater, 37909
- Tennessee Cancer Specialists
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Memphis, Tennessee, Forenede Stater, 38120
- West Clinic
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Memphis, Tennessee, Forenede Stater, 38119
- Family Cancer Center Foundation, Inc.
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Memphis, Tennessee, Forenede Stater, 38104
- Bostin Baskin Cancer Foundation
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Cancer Center
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Research Institute
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Oncology, P.A. - Amarillo
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Beaumont, Texas, Forenede Stater, 77702-1449
- Texas Oncology Beaumont
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Dallas, Texas, Forenede Stater, 75246
- Baylor Charles A Sammons Cancer Center
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Dallas, Texas, Forenede Stater, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
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Flower Mound, Texas, Forenede Stater, 75028
- Texas Oncology - Flower Mound
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Fort Worth, Texas, Forenede Stater, 76132
- Texas Oncology Southwest Forth Worth
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Ft. Worth, Texas, Forenede Stater, 76104
- Texas Oncology, Fort Worth
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Garland, Texas, Forenede Stater, 75042-5788
- Texas Oncology, Garland
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New Braunfels, Texas, Forenede Stater, 78131
- Cancer Care Centers of South Texas - HOAST
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Paris, Texas, Forenede Stater, 75460-5004
- Texas Oncology - Paris
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Plano, Texas, Forenede Stater, 75075-7787
- Texas Oncology - Plano East
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San Antonio, Texas, Forenede Stater, 78229
- Cancer Care Centers of South Texas-HOAST
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Tyler, Texas, Forenede Stater, 75702
- Texas Oncology -Tyler
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Waco, Texas, Forenede Stater, 76712
- Texas Oncology Cancer Care and Research Center
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Virginia
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Christiansburg, Virginia, Forenede Stater, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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Christiansburg, Virginia, Forenede Stater, 24073
- Onc and Hem Associates of SW VA, Inc.
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Hampton, Virginia, Forenede Stater, 23666
- Virginia Oncology Associates
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Newport News, Virginia, Forenede Stater, 23606
- Virginia Oncology Associates
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Norfolk, Virginia, Forenede Stater, 23502
- Virginia Oncology Associates
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Roanoke, Virginia, Forenede Stater, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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Salem, Virginia, Forenede Stater, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
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Wytheville, Virginia, Forenede Stater, 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, Forenede Stater, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
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Spokane, Washington, Forenede Stater, 99218
- Cancer Care Northwest-North
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Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest
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Spokane Valley, Washington, Forenede Stater, 99216
- Cancer Care Northwest-Valley
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Vancouver, Washington, Forenede Stater, 98684
- Northwest Cancer Specialists, P.C.
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Vancouver, Washington, Forenede Stater, 98686
- Northwest Cancer Specialist, P.C.
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-
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-
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Bayonne, Frankrig, 64100
- Centre d'oncologie et de radiothérapie du Pays Basque
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Brest cedex, Frankrig, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
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Caen Cedex, Frankrig, 14033
- CHU de Caen - Service de pneumologie
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Clermont-Ferrand cedex 1, Frankrig, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
-
Lyon cedex 04, Frankrig, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
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Marseille cedex 9, Frankrig, 13273
- Institut Paoli-Calmettes
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PARIS cedex 14, Frankrig, 75014
- Fondation Hôpital Saint Joseph
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Paris, Frankrig, 75012
- Hôpital de Tenon
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Perpignan, Frankrig, 66000
- Centre Catalan d'Oncologie
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Rennes cedex 9, Frankrig, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
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Saint Priest en Jarez, Frankrig, 42271
- Institut de Cancerologie de La Loire
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Vandoeuvre-lès-Nancy Cedex, Frankrig, 54511
- Hôpital de Brabois
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Cedex 9
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Toulouse, Cedex 9, Frankrig, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
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-
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Athens, Grækenland, 15562
- IASO General Hospital of Athens
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Thessaloniki, Grækenland, 54603
- "Papageorgiou" General Hospital of Thessaloniki
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Thessaloniki, Grækenland, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
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Ancona, Italien, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
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Bologna, Italien, 40139
- Ospedale Bellaria
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Catania, Italien, 95100
- Ospedale Garibaldi Nesima
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Genova, Italien, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
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Parma, Italien, 43100
- Azienda Ospedaliero- Universitaria di Parma
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Perugia, Italien, 06132
- Ospedale S. Maria Della Misericordia
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Roma, Italien, 00152
- Azienda Ospedaliera San Camillo Forlanini
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Gyeonggi-Do, Korea, Republikken, 442-723
- Saint Vincent's Hospital
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Incheon, Korea, Republikken, 405-760
- Gachon Medical School Ghil Medical Center
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Seoul, Korea, Republikken, 138-736
- Asan Medical Center
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Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital
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Seoul, Korea, Republikken, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
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Lublin, Polen, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Otwock, Polen, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Poznan, Polen, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
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Szczecin, Polen, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
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Warsaw, Polen, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
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Wroclaw, Polen, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
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Bucuresti, Rumænien, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
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Bucuresti, Rumænien, 022328
- Institutul Oncologic Al. Trestioreanu
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Cluj-Napoca, Rumænien, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Iasi, Rumænien, 700106
- Centrul de Oncologie Medicala
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Sibiu, Rumænien, 550245
- Spitalul Clinic Judetean Sibiu
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Bihor
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Oradea, Bihor, Rumænien, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
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Dolj
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Craiova, Dolj, Rumænien, 200535
- Oncoloab SRL
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-
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Madrid, Spanien, 28033
- Hospital Oncologico MD Anderson
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Málaga, Spanien, 29010
- Hospital Carlos Haya
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Málaga, Spanien, 29010
- Hospital Clínico Virgen de la Victoria
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Pamplona, Spanien, 31008
- Clinica Universitaria de Navarra
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Santander, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Sevilla, Spanien, 41700
- Hospital Universitario de Valme
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Toledo, Spanien, 45004
- Hospital Virgen de la Salud de Toledo
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Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
-
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Barcelona
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L' Hospitalet de Llobregat, Barcelona, Spanien, 08907
- ICO (Institut Catalá d´Oncología)
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Manresa, Barcelona, Spanien, 08243
- Fundacio Althaia
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Sabadell, Barcelona, Spanien, 08208
- Corporació Sanitària Parc Taulí
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Madrid
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Majadahonda, Madrid, Spanien, 28222
- Hospital Puerta de Hierro Majadahonda
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-
-
-
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Changhua, Taiwan, 500-06
- Changhua Christian Hospital
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Kaohsiung, Taiwan, 833
- Chang Gung Medical Foundation
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Taichung, Taiwan, 404
- China Medical University Hospital
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Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Chang Gung memorial hospital
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Ceske Budejovice, Tjekkiet, 370 87
- Nemocnice Ceske Budejovice, a.s.
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Ostrava-Poruba, Tjekkiet, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
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Praha, Tjekkiet, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
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-
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Bad Berka, Tyskland, 99437
- Zentralklinik Bad Berka
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Berlin, Tyskland, 14165
- Helios Klinikum Emil von Behring GmbH
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Bochum, Tyskland, 44791
- Augusta-Krankenanstalt Bochum
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Coswig, Tyskland, 01640
- Fachkrankenhaus Coswig
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Essen, Tyskland, 45122
- Universitaetsklinikum Essen
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Frankfurt/Main, Tyskland, 60488
- Krankenhaus Nordwest
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Freiburg, Tyskland, 79106
- Universitätsklinikum Freiburg
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Großhansdorf, Tyskland, 22927
- LungenClinic Grosshansdorf
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Göttingen, Tyskland, 37075
- Universitätsklinikum Göttingen
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Halle (Saale), Tyskland, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
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Hamburg, Tyskland, 21075
- Asklepios Klinik Harburg
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Heidelberg, Tyskland, 69126
- Thoraxklinik Heidelberg
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Hemer, Tyskland, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
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Karlsruhe, Tyskland, 76137
- St. Vincentius-Kliniken Karlsruhe
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Lübeck, Tyskland, 23538
- Universitaetsklinikum Schleswig-Holstein
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Mainz, Tyskland, 55131
- Universitätsklinikum Mainz
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Muenchen-Gauting, Tyskland, 82131
- Asklepios Klinikum Gauting
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Oldenburg, Tyskland, 26121
- Pius Hospital Oldenburg
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Villingen-Schwenningen, Tyskland, 78050
- Schwarzwald-Baar Klinikum
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-
-
-
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Budapest, Ungarn, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Budapest, Ungarn, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
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Deszk, Ungarn, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
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Pécs, Ungarn, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
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Szekesfehervar, Ungarn, 8000
- Fejer Megyei Szent Gyorgy Korhaz
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Szombathely, Ungarn, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
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-
-
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Innsbruck, Østrig, 6020
- Universitaetsklinikum Innsbruck
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Linz, Østrig, 4021
- Allgemeines Krankenhaus der Stadt Linz
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Salzburg, Østrig, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
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Wien, Østrig, 1130
- Krankenhaus Hietzing
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Wien, Østrig, 1090
- Akh Wien
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Wien, Østrig, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
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Wien, Østrig, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
150 mg tablet
Andre navne:
|
|
Placebo komparator: 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.
|
Placebo tablet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease Free Survival (DFS)
Tidsramme: 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).
|
|
Disease Free Survival (DFS)
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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 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.
|
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 (OS)
Tidsramme: 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.
|
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 in Participants With EGFR Mutation - Positive Tumors
Tidsramme: 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.
|
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 in Participants With EGFR Mutation - Positive Tumors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
7. september 2006
Først indsendt, der opfyldte QC-kriterier
7. september 2006
Først opslået (Skøn)
8. september 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. september 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2015
Sidst verificeret
1. september 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
Andre undersøgelses-id-numre
- OSI-774-302
- 2005-001747-29 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Ikke-småcellet lungekræft
-
AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
-
Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med Placebo
-
SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
-
National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
-
Texas A&M UniversityNutraboltAfsluttetGlucose and Insulin Response
-
Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
-
Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater
-
ItalfarmacoAfsluttetBeckers muskeldystrofiHolland, Italien
-
Universidade Estadual de LondrinaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...AfsluttetSund og rask | Kropssammensætning