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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 września 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1252

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentyna, C1272AAA
        • Hospital de Rehabilitación Respiratoria María Ferrer
      • Mendoza, Argentyna, M5500AYB
        • COIR
      • Rosario, Santa Fe, Argentyna, S2001SBL
        • Hospital Espanol de Rosario
      • Santa Fé, Argentyna, S3000FFU
        • ISIS Centro Especializado De Luce S.A.
  • Australia
      • 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
  • Austria
      • 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
  • Belgia
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgia, 1070
        • Hopital Erasme
      • Charleroi, Belgia, 6000
        • Le Grand Hôpital de Charleroi
      • La Louvière, Belgia, 7100
        • Centre Hospitalier Jolimont-Lobbes
  • Federacja Rosyjska
      • Arkhangelsk, Federacja Rosyjska, 163045
        • State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
      • Kemerovo, Federacja Rosyjska, 650036
        • State Healthcare Institution "Regional Clinical Oncology Dispensary"
      • Krasnodar, Federacja Rosyjska, 350086
        • State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
      • Moscow, Federacja Rosyjska, 105229
        • State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
      • Moscow, Federacja Rosyjska, 115478
        • Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
      • Saint-Petersburg, Federacja Rosyjska, 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, Federacja Rosyjska, 197758
        • Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
      • Saint-Petersburg, Federacja Rosyjska, 198255
        • Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
      • Tomsk, Federacja Rosyjska, 634050
        • Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
      • Yaroslavl, Federacja Rosyjska, 150040
        • State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • Francja
      • Bayonne, Francja, 64100
        • Centre d'oncologie et de radiothérapie du Pays Basque
      • Brest cedex, Francja, 29609
        • C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
      • Caen Cedex, Francja, 14033
        • CHU de Caen - Service de pneumologie
      • Clermont-Ferrand cedex 1, Francja, 63003
        • CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
      • Lyon cedex 04, Francja, 69317
        • Hopital De La Croix-Rousse Service de Pneumologie
      • Marseille cedex 9, Francja, 13273
        • Institut Paoli-Calmettes
      • PARIS cedex 14, Francja, 75014
        • Fondation Hôpital Saint Joseph
      • Paris, Francja, 75012
        • Hôpital de Tenon
      • Perpignan, Francja, 66000
        • Centre Catalan d'Oncologie
      • Rennes cedex 9, Francja, 35033
        • CHU - Hopital Pontchaillou - Service de pneumologie
      • Saint Priest en Jarez, Francja, 42271
        • Institut de Cancerologie de La Loire
      • Vandoeuvre-lès-Nancy Cedex, Francja, 54511
        • Hôpital de Brabois
    • Cedex 9
      • Toulouse, Cedex 9, Francja, 31059
        • CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
  • Grecja
      • Athens, Grecja, 15562
        • IASO General Hospital of Athens
      • Thessaloniki, Grecja, 54603
        • "Papageorgiou" General Hospital of Thessaloniki
      • Thessaloniki, Grecja, 57010
        • "G. Papanikolaou" General Hospital of Thessaloniki
  • Hiszpania
      • Madrid, Hiszpania, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Hiszpania, 28046
        • Hospital Universitario La Paz
      • Madrid, Hiszpania, 28033
        • Hospital Oncologico MD Anderson
      • Málaga, Hiszpania, 29010
        • Hospital Carlos Haya
      • Málaga, Hiszpania, 29010
        • Hospital Clínico Virgen de la Victoria
      • Pamplona, Hiszpania, 31008
        • Clinica Universitaria de Navarra
      • Santander, Hiszpania, 39008
        • Hospital Universitario Marques de Valdecilla
      • Sevilla, Hiszpania, 41700
        • Hospital Universitario de Valme
      • Toledo, Hiszpania, 45004
        • Hospital Virgen de la Salud de Toledo
      • Valencia, Hiszpania, 46014
        • Hospital General Universitario de Valencia
    • Barcelona
      • L' Hospitalet de Llobregat, Barcelona, Hiszpania, 08907
        • ICO (Institut Catalá d´Oncología)
      • Manresa, Barcelona, Hiszpania, 08243
        • Fundacio Althaia
      • Sabadell, Barcelona, Hiszpania, 08208
        • Corporacio Sanitaria Parc Tauli
    • Madrid
      • Majadahonda, Madrid, Hiszpania, 28222
        • Hospital Puerta de Hierro Majadahonda
  • Kanada
      • Toronto, Kanada, M6R 1B5
        • St. Joseph's Health Centre
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Kingston, Ontario, Kanada, K7L 5P9
        • Cancer Center of Southeastern Ontario at Kingston General Hospital
      • Mississauga, Ontario, Kanada, L5M 2N1
        • Trillium Health Partners - Credit Valley Hospital
      • Newmarket, Ontario, Kanada, L3Y 2P9
        • Stronach Regional cancer Centre at Southlake
      • Oshawa, Ontario, Kanada, L1G 2B9
        • RS MacLaughlin Durham Regional Cancer Centre
      • Sault Ste Marie, Ontario, Kanada, P6A 5K7
        • Sault Area Hospital
      • Thunder Bay, Ontario, Kanada, P7B 6V4
        • Thunder Bay Regional Health Science Centre
      • Toronto, Ontario, Kanada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Kanada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Kanada, H3G 1A4
        • Montreal General Hospital
      • Montreal, Quebec, Kanada, H2W 1S6
        • McGill Dept. of Oncology
  • Niemcy
      • Bad Berka, Niemcy, 99437
        • Zentralklinik Bad Berka
      • Berlin, Niemcy, 14165
        • Helios Klinikum Emil von Behring GmbH
      • Bochum, Niemcy, 44791
        • Augusta-Krankenanstalt Bochum
      • Coswig, Niemcy, 01640
        • Fachkrankenhaus Coswig
      • Essen, Niemcy, 45122
        • Universitaetsklinikum Essen
      • Frankfurt/Main, Niemcy, 60488
        • Krankenhaus Nordwest
      • Freiburg, Niemcy, 79106
        • Universitatsklinikum Freiburg
      • Großhansdorf, Niemcy, 22927
        • LungenClinic Grosshansdorf
      • Göttingen, Niemcy, 37075
        • Universitätsklinikum Göttingen
      • Halle (Saale), Niemcy, 06120
        • Städtisches Krankenhaus Martha-Maria, Halle-Dölau
      • Hamburg, Niemcy, 21075
        • Asklepios Klinik Harburg
      • Heidelberg, Niemcy, 69126
        • Thoraxklinik Heidelberg
      • Hemer, Niemcy, 58675
        • Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
      • Karlsruhe, Niemcy, 76137
        • St. Vincentius-Kliniken Karlsruhe
      • Lübeck, Niemcy, 23538
        • Universitaetsklinikum Schleswig-Holstein
      • Mainz, Niemcy, 55131
        • Universitätsklinikum Mainz
      • Muenchen-Gauting, Niemcy, 82131
        • Asklepios Klinikum Gauting
      • Oldenburg, Niemcy, 26121
        • Pius Hospital Oldenburg
      • Villingen-Schwenningen, Niemcy, 78050
        • Schwarzwald-Baar Klinikum
  • Polska
      • Lublin, Polska, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Otwock, Polska, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Poznan, Polska, 60-569
        • Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
      • Szczecin, Polska, 70-891
        • Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
      • Warsaw, Polska, 02-781
        • Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
      • Wroclaw, Polska, 53-439
        • Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
  • Republika Czeska
      • Ceske Budejovice, Republika Czeska, 370 87
        • Nemocnice Ceske Budejovice, a.s.
      • Ostrava-Poruba, Republika Czeska, 70852
        • Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
      • Praha, Republika Czeska, 8 18081
        • FN Bulovka Klinika plincni a hrrudni chirurgie
  • Republika Korei
      • Gyeonggi-Do, Republika Korei, 442-723
        • Saint Vincent's Hospital
      • Incheon, Republika Korei, 405-760
        • Gachon Medical School Ghil Medical Center
      • Seoul, Republika Korei, 138-736
        • Asan Medical Center
      • Seoul, Republika Korei, 110-744
        • Seoul National University Hospital
      • Seoul, Republika Korei, 120-752
        • Severance Hospital, Yonsei Univ. College of Medicine
  • Rumunia
      • Bucuresti, Rumunia, 022328
        • Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
      • Bucuresti, Rumunia, 022328
        • Institutul Oncologic Al. Trestioreanu
      • Cluj-Napoca, Rumunia, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
      • Iasi, Rumunia, 700106
        • Centrul de Oncologie Medicala
      • Sibiu, Rumunia, 550245
        • Spitalul Clinic Judetean Sibiu
    • Bihor
      • Oradea, Bihor, Rumunia, 410032
        • Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
    • Dolj
      • Craiova, Dolj, Rumunia, 200535
        • Oncoloab SRL
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Stany Zjednoczone, 72205
        • University of Arkansas for Medical Science
    • California
      • Beverly Hills, California, Stany Zjednoczone, 90211
        • Tower Cancer Research Foundation
      • Duarte, California, Stany Zjednoczone, 91010
        • City of Hope Nat'l Medical Center
      • Loma Linda, California, Stany Zjednoczone, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Stany Zjednoczone, 90033
        • USC/ Norris Comprehensive Cancer Center
      • Newport Beach, California, Stany Zjednoczone, 92658
        • Hoag Memorial Hospital Presbyterian
      • Palm Springs, California, Stany Zjednoczone, 92262
        • Comprehensive Cancer Center at Desert Regional Medical Center
      • Pleasant Hill, California, Stany Zjednoczone, 94523
        • Bay Area Cancer Research Group, LLC
      • San Francisco, California, Stany Zjednoczone, 94143-1770
        • University of California, San Francisco Comprehensive Cancer Center
      • South Pasadena, California, Stany Zjednoczone, 91030
        • City of Hope Medical Group (COHMG)
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, Stany Zjednoczone, 80012
        • Rocky Mountain Cancer Center- Aurora
      • Boulder, Colorado, Stany Zjednoczone, 80303
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, Stany Zjednoczone, 80907
        • Rocky Mountain Cancer Center
      • Colorado Springs, Colorado, Stany Zjednoczone, 80907
        • Penrose St. Francis Health Services
      • Colorado Springs, Colorado, Stany Zjednoczone, 80909
        • Rocky Mountain Cancer Center
      • Denver, Colorado, Stany Zjednoczone, 80218
        • Rocky Mountain Cancer Center-Midtown
      • Denver, Colorado, Stany Zjednoczone, 80220
        • Rocky Mountain Cancer Centers- Rose
      • Lakewood, Colorado, Stany Zjednoczone, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, Stany Zjednoczone, 80120-4413
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Stany Zjednoczone, 80124
        • Rocky Mountain Cancer Center-Sky Ridge
      • Longmont, Colorado, Stany Zjednoczone, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, Stany Zjednoczone, 80138
        • Rocky Mountain Cancer Center-Parker
      • Thornton, Colorado, Stany Zjednoczone, 80260
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06520
        • Yale University
      • Sharon, Connecticut, Stany Zjednoczone, 06069
        • Smilow Cancer Hospital Care Center
      • Stamford, Connecticut, Stany Zjednoczone, 06902
        • Hematology Oncology, P.C.
      • Torrington, Connecticut, Stany Zjednoczone, 06790
        • Smilow Cancer Hospital Care Center
    • Florida
      • Hudson, Florida, Stany Zjednoczone, 34667
        • Florida Cancer Institute-New Hope
      • Jacksonville, Florida, Stany Zjednoczone, 32204
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32216
        • Cancer Specialists of North Florida
      • Lakeland, Florida, Stany Zjednoczone, 33805
        • Watson Clinic LLP
      • Miami, Florida, Stany Zjednoczone, 33176
        • Advanced Medical Specialties
      • New Port Richey, Florida, Stany Zjednoczone, 34655
        • Florida Cancer Institute- New Hope
      • Orlando, Florida, Stany Zjednoczone, 32806
        • Florida Cancer Specialists
      • Port St. Lucie, Florida, Stany Zjednoczone, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30318
        • Peachtree Hematology-Oncology Consultants, P.C.
      • Macon, Georgia, Stany Zjednoczone, 31201
        • Central Georgia Cancer Care, PC
      • Marietta, Georgia, Stany Zjednoczone, 30060
        • Northwest Georgia Oncology Centers, PC
    • Idaho
      • Boise, Idaho, Stany Zjednoczone, 83712
        • Mountain States Tumor Institute
      • Meridian, Idaho, Stany Zjednoczone, 83642
        • Mountain States Tumor Institute
      • Post Falls, Idaho, Stany Zjednoczone, 83854
        • Kootenai Cancer Center
      • Twin Falls, Idaho, Stany Zjednoczone, 83301
        • Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Stany Zjednoczone, 60637
        • University of Chicago, Section of Hematology/Oncology
      • Joliet, Illinois, Stany Zjednoczone, 60435
        • Joliet Oncology Hematology Assoc., LTD
      • Maywood, Illinois, Stany Zjednoczone, 60153
        • Loyola University Medical Center
    • Indiana
      • Carmel, Indiana, Stany Zjednoczone, 46032
        • Indiana University Health
      • Fishers, Indiana, Stany Zjednoczone, 46037
        • Indiana University Health
      • Greenfield, Indiana, Stany Zjednoczone, 46140
        • Indiana University Health
      • Indianapolis, Indiana, Stany Zjednoczone, 46219
        • Indiana University Health
      • Indianapolis, Indiana, Stany Zjednoczone, 46227
        • Indiana University Health
    • Kansas
      • Westwood, Kansas, Stany Zjednoczone, 66205
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202
        • Norton Healthcare, Inc.
    • Louisiana
      • Houma, Louisiana, Stany Zjednoczone, 70363
        • Leonard J. Chabert Medical Center
    • Maine
      • Brewer, Maine, Stany Zjednoczone, 04412
        • Cancer Care of Maine
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21204
        • Greater Baltimore Medical Center
      • Towson, Maryland, Stany Zjednoczone, 21204
        • St. Joseph Medical Center's Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02135
        • Caritas St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48106
        • St. Joseph Mercy Hospital
    • Minnesota
      • Burnsville, Minnesota, Stany Zjednoczone, 55337
        • Minnesota Oncology Hematology, P.A.
      • Edina, Minnesota, Stany Zjednoczone, 55435-2150
        • Minnesota Oncology Hematology, P.A.
      • Maplewood, Minnesota, Stany Zjednoczone, 55109
        • Minnesota Oncology Hematology, P.A.
      • Minneapolis, Minnesota, Stany Zjednoczone, 55404
        • Minnesota Oncology Hematology, P.A.
      • St. Paul, Minnesota, Stany Zjednoczone, 55102-2389
        • Minnesota Oncology Hematology
      • Woodbury, Minnesota, Stany Zjednoczone, 55125
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, Stany Zjednoczone, 65201
        • Missouri Cancer Associates
      • St. Joseph, Missouri, Stany Zjednoczone, 64507
        • Heartland Regional Medical Center d/b/a Heartland Clinic
    • Nebraska
      • Grand Island, Nebraska, Stany Zjednoczone, 68803
        • St. Francis Cancer Treatment Center
      • Omaha, Nebraska, Stany Zjednoczone, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Henderson, Nevada, Stany Zjednoczone, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Concord, New Hampshire, Stany Zjednoczone, 03301
        • NH Oncology-Hematology PA (Co)
      • Hooksett, New Hampshire, Stany Zjednoczone, 03106
        • NH Oncology-Hematology PA
      • Lebanon, New Hampshire, Stany Zjednoczone, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87131
        • University of New Mexico Health Science Center
      • Santa Fe, New Mexico, Stany Zjednoczone, 87505
        • Christus St. Vincent Regional Cancer Center
    • New York
      • Brockport, New York, Stany Zjednoczone, 14420
        • Interlakes Oncology Hematology, PC
      • Bronx, New York, Stany Zjednoczone, 10467
        • Montefiore Medical Center
      • Canadaigua, New York, Stany Zjednoczone, 14424
        • Interlakes Oncology Hematology, PC
      • Geneva, New York, Stany Zjednoczone, 14456
        • Interlakes Oncology Hematology, PC
      • New Rochelle, New York, Stany Zjednoczone, 10801
        • Advanced Oncology Associates
      • New York, New York, Stany Zjednoczone, 10065
        • The New York Presbyterian-Weill Medical College of Cornell University
      • Rochester, New York, Stany Zjednoczone, 14623
        • Interlakes Oncology Hematology, PC
      • Rochester, New York, Stany Zjednoczone, 14626
        • Interlakes Oncology Hematology, PC
      • Stony Brook, New York, Stany Zjednoczone, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Cary, North Carolina, Stany Zjednoczone, 27511
        • Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
      • Hickory, North Carolina, Stany Zjednoczone, 28602
        • Carolina Oncology Specialists PA
      • Raleigh, North Carolina, Stany Zjednoczone, 27607
        • Raleigh Hematology Oncology Associates
      • Raleigh, North Carolina, Stany Zjednoczone, 27609
        • Raleigh Hematology Oncology Associates
    • Ohio
      • Canton, Ohio, Stany Zjednoczone, 44710
        • Aultman Hospital/ North Canton Medical Foundation
      • Cleveland, Ohio, Stany Zjednoczone, 44106
        • University Hopsitals of Cleveland
      • Columbus, Ohio, Stany Zjednoczone, 43228
        • Hematology Oncology Consultants Inc.
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97213
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, Stany Zjednoczone, 97225
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, Stany Zjednoczone, 97227
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, Stany Zjednoczone, 97213
        • Earle A Chiles Research Institute
      • Tualatin, Oregon, Stany Zjednoczone, 97062
        • Northwest Cancer Specialists, PC
    • Pennsylvania
      • Bethlehem, Pennsylvania, Stany Zjednoczone, 18015
        • Cancer Care Associates - Medical Oncology
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • The Hospital of the University of Pennsylvania
      • Pittsburg, Pennsylvania, Stany Zjednoczone, 15212
        • Allegheny General Hospital
    • South Carolina
      • Columbia, South Carolina, Stany Zjednoczone, 29210
        • South Carolina Oncology Assoc., PA
      • Easley, South Carolina, Stany Zjednoczone, 29640
        • Cancer Centers of the Carolinas
      • Greenville, South Carolina, Stany Zjednoczone, 29605
        • Cancer Centers of the Carolinas
      • Greenville, South Carolina, Stany Zjednoczone, 29615
        • Cancer Centers of the Carolinas
      • Seneca, South Carolina, Stany Zjednoczone, 29672
        • Cancer Centers of the Carolinas, Seneca
      • Spartanburg, South Carolina, Stany Zjednoczone, 29307
        • Cancer Centers of the Carolinas
    • Tennessee
      • Cookeville, Tennessee, Stany Zjednoczone, 38501
        • Cookeville Regional Medical Center
      • Germantown, Tennessee, Stany Zjednoczone, 38138
        • Bostin Baskin Cancer Foundation
      • Knoxville, Tennessee, Stany Zjednoczone, 37909
        • Tennessee Cancer Specialists
      • Memphis, Tennessee, Stany Zjednoczone, 38120
        • West Clinic
      • Memphis, Tennessee, Stany Zjednoczone, 38119
        • Family Cancer Center Foundation, Inc.
      • Memphis, Tennessee, Stany Zjednoczone, 38104
        • Bostin Baskin Cancer Foundation
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Sarah Cannon Cancer Center
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Amarillo, Texas, Stany Zjednoczone, 79106
        • Texas Oncology, P.A. - Amarillo
      • Beaumont, Texas, Stany Zjednoczone, 77702-1449
        • Texas Oncology Beaumont
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Baylor Charles A Sammons Cancer Center
      • Dallas, Texas, Stany Zjednoczone, 75230-2510
        • Texas Oncology Texas Cancer Center at Medical City
      • Flower Mound, Texas, Stany Zjednoczone, 75028
        • Texas Oncology - Flower Mound
      • Fort Worth, Texas, Stany Zjednoczone, 76132
        • Texas Oncology Southwest Forth Worth
      • Ft. Worth, Texas, Stany Zjednoczone, 76104
        • Texas Oncology, Fort Worth
      • Garland, Texas, Stany Zjednoczone, 75042-5788
        • Texas Oncology, Garland
      • New Braunfels, Texas, Stany Zjednoczone, 78131
        • Cancer Care Centers of South Texas - HOAST
      • Paris, Texas, Stany Zjednoczone, 75460-5004
        • Texas Oncology - Paris
      • Plano, Texas, Stany Zjednoczone, 75075-7787
        • Texas Oncology - Plano East
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Cancer Care Centers of South Texas-HOAST
      • Tyler, Texas, Stany Zjednoczone, 75702
        • Texas Oncology -Tyler
      • Waco, Texas, Stany Zjednoczone, 76712
        • Texas Oncology Cancer Care and Research Center
    • Virginia
      • Christiansburg, Virginia, Stany Zjednoczone, 24073
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
      • Christiansburg, Virginia, Stany Zjednoczone, 24073
        • Onc and Hem Associates of SW VA, Inc.
      • Hampton, Virginia, Stany Zjednoczone, 23666
        • Virginia Oncology Associates
      • Newport News, Virginia, Stany Zjednoczone, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, Stany Zjednoczone, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, Stany Zjednoczone, 24014
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
      • Salem, Virginia, Stany Zjednoczone, 24153
        • Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
      • Wytheville, Virginia, Stany Zjednoczone, 24382
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109
        • Univ. of Washington/ Seattle Cancer Care Alliance
      • Spokane, Washington, Stany Zjednoczone, 99218
        • Cancer Care Northwest-North
      • Spokane, Washington, Stany Zjednoczone, 99202
        • Cancer Care Northwest
      • Spokane Valley, Washington, Stany Zjednoczone, 99216
        • Cancer Care Northwest-Valley
      • Vancouver, Washington, Stany Zjednoczone, 98684
        • Northwest Cancer Specialists, P.C.
      • Vancouver, Washington, Stany Zjednoczone, 98686
        • Northwest Cancer Specialist, P.C.
  • Tajwan
      • Changhua, Tajwan, 500-06
        • Changhua Christian Hospital
      • Kaohsiung, Tajwan, 833
        • Chang Gung Medical Foundation
      • Taichung, Tajwan, 404
        • China Medical University Hospital
      • Taichung, Tajwan, 402
        • Chung Shan Medical University Hospital
      • Taichung, Tajwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Tajwan, 112
        • Taipei Veterans General Hospital
      • Taoyuan, Tajwan, 333
        • Chang Gung memorial hospital
  • Węgry
      • Budapest, Węgry, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Budapest, Węgry, 1125
        • Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
      • Deszk, Węgry, 6772
        • Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
      • Pécs, Węgry, 7623
        • Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
      • Szekesfehervar, Węgry, 8000
        • Fejer Megyei Szent Gyorgy Korhaz
      • Szombathely, Węgry, 9700
        • Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
  • Włochy
      • Ancona, Włochy, 60020
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
      • Bologna, Włochy, 40139
        • Ospedale Bellaria
      • Catania, Włochy, 95100
        • Ospedale Garibaldi Nesima
      • Genova, Włochy, 16132
        • Istituto Nazionale per la Ricerca e la Cura del Cancro
      • Parma, Włochy, 43100
        • Azienda Ospedaliero- Universitaria di Parma
      • Perugia, Włochy, 06132
        • Ospedale S. Maria Della Misericordia
      • Roma, Włochy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
  • Zjednoczone Królestwo
      • Birmingham, Zjednoczone Królestwo, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, Zjednoczone Królestwo, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Dundee, Zjednoczone Królestwo, DD1 9SY
        • Ninewells Hospital
      • Glasgow, Zjednoczone Królestwo, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Guildford, Zjednoczone Królestwo, GU2 7XX
        • The Royal Surrey County Hospital NHS Trust
      • Lecester, Zjednoczone Królestwo, LE1 5WW
        • Leicester Royal Infirmary
      • Leeds, Zjednoczone Królestwo, LS9 7TF
        • St James' Institute of Oncology, Bexley Wing, St James' University Hospital
      • London, Zjednoczone Królestwo, SE1 9RT
        • Guy's Hospital
      • London, Zjednoczone Królestwo, SW3 6JJ
        • Royal Marsden Hospital
      • Sutton, Zjednoczone Królestwo, SM2 5PT
        • Royal Marsden Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests
  • Patients may have up to 4 cycles of chemotherapy after surgery
  • Complete removal of the tumor by surgery

  • Able to start drug under the following timelines:

    • 6 months from the day of surgery for patients who get chemotherapy
    • 3 months from the day of surgery for those who do not get chemotherapy
  • Confirmed diagnosis of Stage IB-IIIA NSCLC
  • Patients must be accessible for follow-up visits

Exclusion Criteria:

  • History of prior radiotherapy for NSCLC either before or after surgery
  • History of heart disease or uncontrolled heart arrhythmias within the previous year
  • History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug
  • History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
  • Patients who have received chemotherapy for NSCLC before surgery
  • Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Erlotinib
150 mg tablet
Inne nazwy:
  • Tarcewa
  • OSI-774
Komparator 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.
Lek: Placebo
Tabletka placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disease Free Survival (DFS)
Ramy czasowe: 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)
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

OSI Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2006

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2013

Ukończenie studiów (Rzeczywisty)

1 czerwca 2014

Daty rejestracji na studia

Pierwszy przesłany

7 września 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2006

Pierwszy wysłany (Oszacować)

8 września 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

17 września 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 września 2015

Ostatnia weryfikacja

1 września 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OSI-774-302
  • 2005-001747-29 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Niedrobnokomórkowego raka płuca

Badania kliniczne na Placebo

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Warunki medyczne

Interwencje lekowe

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CROs in Austria

Warunki

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