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 settembre 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
1252
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
-
Buenos Aires, Argentina, C1272AAA
- Hospital de Rehabilitación Respiratoria María Ferrer
-
Mendoza, Argentina, M5500AYB
- COIR
-
Rosario, Santa Fe, Argentina, S2001SBL
- Hospital Espanol de Rosario
-
Santa Fé, Argentina, S3000FFU
- ISIS Centro Especializado De Luce S.A.
-
-
-
-
-
Adelaide, Australia, 5067
- Respiratory Clinical Trials Pty., Ltd
-
Ashford, Australia, SA 5037
- Ashford Cancer Centre
-
-
New South Wales
-
Campbelltown, New South Wales, Australia, 2560
- Campbelltown Hospital
-
Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
-
St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
-
-
Victoria
-
East Bentleigh, Victoria, Australia, 3165
- Monash Medical Centre
-
Fitzroy, Victoria, Australia, 3065
- St Vincent's Hospital Melbourne
-
Heidelberg, Victoria, Australia, 3084
- Austin Hospital
-
-
-
-
-
Innsbruck, Austria, 6020
- Universitaetsklinikum Innsbruck
-
Linz, Austria, 4021
- Allgemeines Krankenhaus der Stadt Linz
-
Salzburg, Austria, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
-
Wien, Austria, 1130
- Krankenhaus Hietzing
-
Wien, Austria, 1090
- AKH Wien
-
Wien, Austria, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
-
Wien, Austria, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
-
-
-
-
-
Brussels, Belgio, 1200
- Cliniques universitaires Saint-Luc
-
Brussels, Belgio, 1070
- Hopital Erasme
-
Charleroi, Belgio, 6000
- Le Grand Hôpital de Charleroi
-
La Louvière, Belgio, 7100
- Centre Hospitalier Jolimont-Lobbes
-
-
-
-
-
Toronto, Canada, M6R 1B5
- St. Joseph's Health Centre
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5P9
- Cancer Center of Southeastern Ontario at Kingston General Hospital
-
Mississauga, Ontario, Canada, L5M 2N1
- Trillium Health Partners - Credit Valley Hospital
-
Newmarket, Ontario, Canada, L3Y 2P9
- Stronach Regional cancer Centre at Southlake
-
Oshawa, Ontario, Canada, L1G 2B9
- RS MacLaughlin Durham Regional Cancer Centre
-
Sault Ste Marie, Ontario, Canada, P6A 5K7
- Sault Area Hospital
-
Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Science Centre
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital
-
Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
-
Montreal, Quebec, Canada, H2W 1S6
- McGill Dept. of Oncology
-
-
-
-
-
Gyeonggi-Do, Corea, Repubblica di, 442-723
- Saint Vincent's Hospital
-
Incheon, Corea, Repubblica di, 405-760
- Gachon Medical School Ghil Medical Center
-
Seoul, Corea, Repubblica di, 138-736
- Asan Medical Center
-
Seoul, Corea, Repubblica di, 110-744
- Seoul National University Hospital
-
Seoul, Corea, Repubblica di, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
-
-
-
-
-
Arkhangelsk, Federazione Russa, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
-
Kemerovo, Federazione Russa, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
-
Krasnodar, Federazione Russa, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
-
Moscow, Federazione Russa, 105229
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
-
Moscow, Federazione Russa, 115478
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
-
Saint-Petersburg, Federazione Russa, 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"
-
Saint-Petersburg, Federazione Russa, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
-
Saint-Petersburg, Federazione Russa, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
-
Tomsk, Federazione Russa, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
-
Yaroslavl, Federazione Russa, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
-
-
-
-
-
Bayonne, Francia, 64100
- Centre d'Oncologie et de Radiotherapie du pays Basque
-
Brest cedex, Francia, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
-
Caen Cedex, Francia, 14033
- CHU de Caen - Service de pneumologie
-
Clermont-Ferrand cedex 1, Francia, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
-
Lyon cedex 04, Francia, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
-
Marseille cedex 9, Francia, 13273
- Institut Paoli-Calmettes
-
PARIS cedex 14, Francia, 75014
- Fondation Hopital Saint Joseph
-
Paris, Francia, 75012
- Hôpital de Tenon
-
Perpignan, Francia, 66000
- Centre Catalan d'Oncologie
-
Rennes cedex 9, Francia, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
-
Saint Priest en Jarez, Francia, 42271
- Institut de Cancérologie de la Loire
-
Vandoeuvre-lès-Nancy Cedex, Francia, 54511
- Hôpital de Brabois
-
-
Cedex 9
-
Toulouse, Cedex 9, Francia, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
-
-
-
-
-
Bad Berka, Germania, 99437
- Zentralklinik Bad Berka
-
Berlin, Germania, 14165
- Helios Klinikum Emil von Behring GmbH
-
Bochum, Germania, 44791
- Augusta-Krankenanstalt Bochum
-
Coswig, Germania, 01640
- Fachkrankenhaus Coswig
-
Essen, Germania, 45122
- Universitaetsklinikum Essen
-
Frankfurt/Main, Germania, 60488
- Krankenhaus Nordwest
-
Freiburg, Germania, 79106
- Universitatsklinikum Freiburg
-
Großhansdorf, Germania, 22927
- LungenClinic Grosshansdorf
-
Göttingen, Germania, 37075
- Universitätsklinikum Göttingen
-
Halle (Saale), Germania, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
-
Hamburg, Germania, 21075
- Asklepios Klinik Harburg
-
Heidelberg, Germania, 69126
- Thoraxklinik Heidelberg
-
Hemer, Germania, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
-
Karlsruhe, Germania, 76137
- St. Vincentius-Kliniken Karlsruhe
-
Lübeck, Germania, 23538
- Universitaetsklinikum Schleswig-Holstein
-
Mainz, Germania, 55131
- Universitätsklinikum Mainz
-
Muenchen-Gauting, Germania, 82131
- Asklepios Klinikum Gauting
-
Oldenburg, Germania, 26121
- Pius Hospital Oldenburg
-
Villingen-Schwenningen, Germania, 78050
- Schwarzwald-Baar Klinikum
-
-
-
-
-
Athens, Grecia, 15562
- IASO General Hospital of Athens
-
Thessaloniki, Grecia, 54603
- "Papageorgiou" General Hospital of Thessaloniki
-
Thessaloniki, Grecia, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
-
-
-
-
-
Ancona, Italia, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
-
Bologna, Italia, 40139
- Ospedale Bellaria
-
Catania, Italia, 95100
- Ospedale Garibaldi Nesima
-
Genova, Italia, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
-
Parma, Italia, 43100
- Azienda Ospedaliero- Universitaria di Parma
-
Perugia, Italia, 06132
- Ospedale S. Maria Della Misericordia
-
Roma, Italia, 00152
- Azienda Ospedaliera San Camillo Forlanini
-
-
-
-
-
Lublin, Polonia, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
-
Otwock, Polonia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
-
Poznan, Polonia, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
-
Szczecin, Polonia, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
-
Warsaw, Polonia, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
-
Wroclaw, Polonia, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
-
-
-
-
-
Birmingham, Regno Unito, B9 5SS
- Birmingham Heartlands Hospital
-
Bristol, Regno Unito, BS2 8ED
- Bristol Haematology and Oncology Centre
-
Dundee, Regno Unito, DD1 9SY
- Ninewells Hospital
-
Glasgow, Regno Unito, G12 0YN
- Beatson West of Scotland Cancer Centre
-
Guildford, Regno Unito, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
-
Lecester, Regno Unito, LE1 5WW
- Leicester Royal Infirmary
-
Leeds, Regno Unito, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
-
London, Regno Unito, SE1 9RT
- Guy's Hospital
-
London, Regno Unito, SW3 6JJ
- Royal Marsden Hospital
-
Sutton, Regno Unito, SM2 5PT
- Royal Marsden Hospital
-
-
-
-
-
Ceske Budejovice, Repubblica Ceca, 370 87
- Nemocnice České Budějovice, a.s.
-
Ostrava-Poruba, Repubblica Ceca, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
-
Praha, Repubblica Ceca, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
-
-
-
-
-
Bucuresti, Romania, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
-
Bucuresti, Romania, 022328
- Institutul Oncologic Al. Trestioreanu
-
Cluj-Napoca, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
Iasi, Romania, 700106
- Centrul de Oncologie Medicala
-
Sibiu, Romania, 550245
- Spitalul Clinic Judetean Sibiu
-
-
Bihor
-
Oradea, Bihor, Romania, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
-
-
Dolj
-
Craiova, Dolj, Romania, 200535
- Oncoloab SRL
-
-
-
-
-
Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spagna, 28046
- Hospital Universitario La Paz
-
Madrid, Spagna, 28033
- Hospital Oncologico MD Anderson
-
Málaga, Spagna, 29010
- Hospital Carlos Haya
-
Málaga, Spagna, 29010
- Hospital Clínico Virgen de la Victoria
-
Pamplona, Spagna, 31008
- Clinica Universitaria de Navarra
-
Santander, Spagna, 39008
- Hospital Universitario Marqués de Valdecilla
-
Sevilla, Spagna, 41700
- Hospital Universitario de Valme
-
Toledo, Spagna, 45004
- Hospital Virgen de la Salud de Toledo
-
Valencia, Spagna, 46014
- Hospital General Universitario de Valencia
-
-
Barcelona
-
L' Hospitalet de Llobregat, Barcelona, Spagna, 08907
- ICO (Institut Catalá d´Oncología)
-
Manresa, Barcelona, Spagna, 08243
- Fundació Althaia
-
Sabadell, Barcelona, Spagna, 08208
- Corporacio Sanitaria Parc Tauli
-
-
Madrid
-
Majadahonda, Madrid, Spagna, 28222
- Hospital Puerta de Hierro Majadahonda
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama at Birmingham
-
-
Arizona
-
Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center
-
-
Arkansas
-
Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Science
-
-
California
-
Beverly Hills, California, Stati Uniti, 90211
- Tower Cancer Research Foundation
-
Duarte, California, Stati Uniti, 91010
- City of Hope Nat'l Medical Center
-
Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Medical Center
-
Los Angeles, California, Stati Uniti, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Stati Uniti, 90033
- USC/ Norris Comprehensive Cancer Center
-
Newport Beach, California, Stati Uniti, 92658
- Hoag Memorial Hospital Presbyterian
-
Palm Springs, California, Stati Uniti, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
-
Pleasant Hill, California, Stati Uniti, 94523
- Bay Area Cancer Research Group, LLC
-
San Francisco, California, Stati Uniti, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
-
South Pasadena, California, Stati Uniti, 91030
- City of Hope Medical Group (COHMG)
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045
- University Of Colorado Hospital
-
Aurora, Colorado, Stati Uniti, 80012
- Rocky Mountain Cancer Center- Aurora
-
Boulder, Colorado, Stati Uniti, 80303
- Rocky Mountain Cancer Centers-Boulder
-
Colorado Springs, Colorado, Stati Uniti, 80907
- Rocky Mountain Cancer Center
-
Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose St. Francis Health Services
-
Colorado Springs, Colorado, Stati Uniti, 80909
- Rocky Mountain Cancer Center
-
Denver, Colorado, Stati Uniti, 80218
- Rocky Mountain Cancer Center-Midtown
-
Denver, Colorado, Stati Uniti, 80220
- Rocky Mountain Cancer Centers- Rose
-
Lakewood, Colorado, Stati Uniti, 80228
- Rocky Mountain Cancer Centers
-
Littleton, Colorado, Stati Uniti, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Stati Uniti, 80124
- Rocky Mountain Cancer Center-Sky Ridge
-
Longmont, Colorado, Stati Uniti, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Parker, Colorado, Stati Uniti, 80138
- Rocky Mountain Cancer Center-Parker
-
Thornton, Colorado, Stati Uniti, 80260
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06520
- Yale University
-
Sharon, Connecticut, Stati Uniti, 06069
- Smilow Cancer Hospital Care Center
-
Stamford, Connecticut, Stati Uniti, 06902
- Hematology Oncology, P.C.
-
Torrington, Connecticut, Stati Uniti, 06790
- Smilow Cancer Hospital Care Center
-
-
Florida
-
Hudson, Florida, Stati Uniti, 34667
- Florida Cancer Institute-New Hope
-
Jacksonville, Florida, Stati Uniti, 32204
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Stati Uniti, 32216
- Cancer Specialists of North Florida
-
Lakeland, Florida, Stati Uniti, 33805
- Watson Clinic LLP
-
Miami, Florida, Stati Uniti, 33176
- Advanced Medical Specialties
-
New Port Richey, Florida, Stati Uniti, 34655
- Florida Cancer Institute- New Hope
-
Orlando, Florida, Stati Uniti, 32806
- Florida Cancer Specialists
-
Port St. Lucie, Florida, Stati Uniti, 34952
- Hematology Oncology Associates of the Treasure Coast
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
-
Macon, Georgia, Stati Uniti, 31201
- Central Georgia Cancer Care, PC
-
Marietta, Georgia, Stati Uniti, 30060
- Northwest Georgia Oncology Centers, PC
-
-
Idaho
-
Boise, Idaho, Stati Uniti, 83712
- Mountain States Tumor Institute
-
Meridian, Idaho, Stati Uniti, 83642
- Mountain States Tumor Institute
-
Post Falls, Idaho, Stati Uniti, 83854
- Kootenai Cancer Center
-
Twin Falls, Idaho, Stati Uniti, 83301
- Mountain States Tumor Institute
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
-
Chicago, Illinois, Stati Uniti, 60637
- University of Chicago, Section of Hematology/Oncology
-
Joliet, Illinois, Stati Uniti, 60435
- Joliet Oncology Hematology Assoc., LTD
-
Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
-
-
Indiana
-
Carmel, Indiana, Stati Uniti, 46032
- Indiana University Health
-
Fishers, Indiana, Stati Uniti, 46037
- Indiana University Health
-
Greenfield, Indiana, Stati Uniti, 46140
- Indiana University Health
-
Indianapolis, Indiana, Stati Uniti, 46219
- Indiana University Health
-
Indianapolis, Indiana, Stati Uniti, 46227
- Indiana University Health
-
-
Kansas
-
Westwood, Kansas, Stati Uniti, 66205
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Stati Uniti, 40202
- Norton Healthcare, Inc.
-
-
Louisiana
-
Houma, Louisiana, Stati Uniti, 70363
- Leonard J. Chabert Medical Center
-
-
Maine
-
Brewer, Maine, Stati Uniti, 04412
- Cancer Care of Maine
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21204
- Greater Baltimore Medical Center
-
Towson, Maryland, Stati Uniti, 21204
- St. Joseph Medical Center's Cancer Institute
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02135
- Caritas St. Elizabeth's Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48106
- St. Joseph Mercy Hospital
-
-
Minnesota
-
Burnsville, Minnesota, Stati Uniti, 55337
- Minnesota Oncology Hematology, P.A.
-
Edina, Minnesota, Stati Uniti, 55435-2150
- Minnesota Oncology Hematology, P.A.
-
Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology, P.A.
-
Minneapolis, Minnesota, Stati Uniti, 55404
- Minnesota Oncology Hematology, P.A.
-
St. Paul, Minnesota, Stati Uniti, 55102-2389
- Minnesota Oncology Hematology
-
Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology, P.A.
-
-
Missouri
-
Columbia, Missouri, Stati Uniti, 65201
- Missouri Cancer Associates
-
St. Joseph, Missouri, Stati Uniti, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
-
-
Nebraska
-
Grand Island, Nebraska, Stati Uniti, 68803
- St. Francis Cancer Treatment Center
-
Omaha, Nebraska, Stati Uniti, 68114
- Nebraska Methodist Hospital
-
-
Nevada
-
Henderson, Nevada, Stati Uniti, 89052
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stati Uniti, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stati Uniti, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stati Uniti, 89169
- Comprehensive Cancer Centers of Nevada
-
-
New Hampshire
-
Concord, New Hampshire, Stati Uniti, 03301
- NH Oncology-Hematology PA (Co)
-
Hooksett, New Hampshire, Stati Uniti, 03106
- NH Oncology-Hematology PA
-
Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti, 87131
- University of New Mexico Health Science Center
-
Santa Fe, New Mexico, Stati Uniti, 87505
- CHRISTUS St. Vincent Regional Cancer Center
-
-
New York
-
Brockport, New York, Stati Uniti, 14420
- Interlakes Oncology Hematology, PC
-
Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
-
Canadaigua, New York, Stati Uniti, 14424
- Interlakes Oncology Hematology, PC
-
Geneva, New York, Stati Uniti, 14456
- Interlakes Oncology Hematology, PC
-
New Rochelle, New York, Stati Uniti, 10801
- Advanced Oncology Associates
-
New York, New York, Stati Uniti, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
-
Rochester, New York, Stati Uniti, 14623
- Interlakes Oncology Hematology, PC
-
Rochester, New York, Stati Uniti, 14626
- Interlakes Oncology Hematology, PC
-
Stony Brook, New York, Stati Uniti, 11794
- Stony Brook University Medical Center
-
-
North Carolina
-
Cary, North Carolina, Stati Uniti, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
-
Hickory, North Carolina, Stati Uniti, 28602
- Carolina Oncology Specialists PA
-
Raleigh, North Carolina, Stati Uniti, 27607
- Raleigh Hematology Oncology Associates
-
Raleigh, North Carolina, Stati Uniti, 27609
- Raleigh Hematology Oncology Associates
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44710
- Aultman Hospital/ North Canton Medical Foundation
-
Cleveland, Ohio, Stati Uniti, 44106
- University Hopsitals of Cleveland
-
Columbus, Ohio, Stati Uniti, 43228
- Hematology Oncology Consultants Inc.
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97213
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Stati Uniti, 97225
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Stati Uniti, 97227
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Stati Uniti, 97213
- Earle A Chiles Research Institute
-
Tualatin, Oregon, Stati Uniti, 97062
- Northwest Cancer Specialists, PC
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Stati Uniti, 18015
- Cancer Care Associates - Medical Oncology
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- The Hospital of the University of Pennsylvania
-
Pittsburg, Pennsylvania, Stati Uniti, 15212
- Allegheny General Hospital
-
-
South Carolina
-
Columbia, South Carolina, Stati Uniti, 29210
- South Carolina Oncology Assoc., PA
-
Easley, South Carolina, Stati Uniti, 29640
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Stati Uniti, 29605
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Stati Uniti, 29615
- Cancer Centers of the Carolinas
-
Seneca, South Carolina, Stati Uniti, 29672
- Cancer Centers of the Carolinas, Seneca
-
Spartanburg, South Carolina, Stati Uniti, 29307
- Cancer Centers of the Carolinas
-
-
Tennessee
-
Cookeville, Tennessee, Stati Uniti, 38501
- Cookeville Regional Medical Center
-
Germantown, Tennessee, Stati Uniti, 38138
- Bostin Baskin Cancer Foundation
-
Knoxville, Tennessee, Stati Uniti, 37909
- Tennessee Cancer Specialists
-
Memphis, Tennessee, Stati Uniti, 38120
- West Clinic
-
Memphis, Tennessee, Stati Uniti, 38119
- Family Cancer Center Foundation, Inc.
-
Memphis, Tennessee, Stati Uniti, 38104
- Bostin Baskin Cancer Foundation
-
Nashville, Tennessee, Stati Uniti, 37203
- Sarah Cannon Cancer Center
-
Nashville, Tennessee, Stati Uniti, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Amarillo, Texas, Stati Uniti, 79106
- Texas Oncology, P.A. - Amarillo
-
Beaumont, Texas, Stati Uniti, 77702-1449
- Texas Oncology Beaumont
-
Dallas, Texas, Stati Uniti, 75246
- Baylor Charles A Sammons Cancer Center
-
Dallas, Texas, Stati Uniti, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
-
Flower Mound, Texas, Stati Uniti, 75028
- Texas Oncology - Flower Mound
-
Fort Worth, Texas, Stati Uniti, 76132
- Texas Oncology Southwest Forth Worth
-
Ft. Worth, Texas, Stati Uniti, 76104
- Texas Oncology, Fort Worth
-
Garland, Texas, Stati Uniti, 75042-5788
- Texas Oncology, Garland
-
New Braunfels, Texas, Stati Uniti, 78131
- Cancer Care Centers of South Texas - HOAST
-
Paris, Texas, Stati Uniti, 75460-5004
- Texas Oncology - Paris
-
Plano, Texas, Stati Uniti, 75075-7787
- Texas Oncology - Plano East
-
San Antonio, Texas, Stati Uniti, 78229
- Cancer Care Centers of South Texas-HOAST
-
Tyler, Texas, Stati Uniti, 75702
- Texas Oncology -Tyler
-
Waco, Texas, Stati Uniti, 76712
- Texas Oncology Cancer Care and Research Center
-
-
Virginia
-
Christiansburg, Virginia, Stati Uniti, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Christiansburg, Virginia, Stati Uniti, 24073
- Onc and Hem Associates of SW VA, Inc.
-
Hampton, Virginia, Stati Uniti, 23666
- Virginia Oncology Associates
-
Newport News, Virginia, Stati Uniti, 23606
- Virginia Oncology Associates
-
Norfolk, Virginia, Stati Uniti, 23502
- Virginia Oncology Associates
-
Roanoke, Virginia, Stati Uniti, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Salem, Virginia, Stati Uniti, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
-
Wytheville, Virginia, Stati Uniti, 24382
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
-
Spokane, Washington, Stati Uniti, 99218
- Cancer Care Northwest-North
-
Spokane, Washington, Stati Uniti, 99202
- Cancer Care Northwest
-
Spokane Valley, Washington, Stati Uniti, 99216
- Cancer Care Northwest-Valley
-
Vancouver, Washington, Stati Uniti, 98684
- Northwest Cancer Specialists, P.C.
-
Vancouver, Washington, Stati Uniti, 98686
- Northwest Cancer Specialist, P.C.
-
-
-
-
-
Changhua, Taiwan, 500-06
- Changhua Christian Hospital
-
Kaohsiung, Taiwan, 833
- Chang Gung Medical Foundation
-
Taichung, Taiwan, 404
- China Medical University Hospital
-
Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
-
Taichung, Taiwan, 407
- Taichung Veterans General Hospital
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital
-
Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
-
-
-
Budapest, Ungheria, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
-
Budapest, Ungheria, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
-
Deszk, Ungheria, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
-
Pécs, Ungheria, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
-
Szekesfehervar, Ungheria, 8000
- Fejer Megyei Szent Gyorgy Korhaz
-
Szombathely, Ungheria, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
|
|
Comparatore placebo: 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.
|
Compressa placebo
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Disease Free Survival (DFS)
Lasso di tempo: 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)
Lasso di tempo: 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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2006
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
7 settembre 2006
Primo inviato che soddisfa i criteri di controllo qualità
7 settembre 2006
Primo Inserito (Stima)
8 settembre 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
17 settembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2015
Ultimo verificato
1 settembre 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Erlotinib cloridrato
Altri numeri di identificazione dello studio
- OSI-774-302
- 2005-001747-29 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .