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 сентября 2015 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
1252
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Adelaide, Австралия, 5067
- Respiratory Clinical Trials Pty., Ltd
-
Ashford, Австралия, SA 5037
- Ashford Cancer Centre
-
-
New South Wales
-
Campbelltown, New South Wales, Австралия, 2560
- Campbelltown Hospital
-
Liverpool, New South Wales, Австралия, 2170
- Liverpool Hospital
-
St Leonards, New South Wales, Австралия, 2065
- Royal North Shore Hospital
-
-
Victoria
-
East Bentleigh, Victoria, Австралия, 3165
- Monash Medical Centre
-
Fitzroy, Victoria, Австралия, 3065
- St Vincent's Hospital Melbourne
-
Heidelberg, Victoria, Австралия, 3084
- Austin Hospital
-
-
-
-
-
Innsbruck, Австрия, 6020
- Universitaetsklinikum Innsbruck
-
Linz, Австрия, 4021
- Allgemeines Krankenhaus der Stadt Linz
-
Salzburg, Австрия, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
-
Wien, Австрия, 1130
- Krankenhaus Hietzing
-
Wien, Австрия, 1090
- Akh Wien
-
Wien, Австрия, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
-
Wien, Австрия, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
-
-
-
-
-
Buenos Aires, Аргентина, C1181ACH
- Hospital Italiano de Buenos Aires
-
Buenos Aires, Аргентина, C1272AAA
- Hospital de Rehabilitación Respiratoria María Ferrer
-
Mendoza, Аргентина, M5500AYB
- COIR
-
Rosario, Santa Fe, Аргентина, S2001SBL
- Hospital Espanol de Rosario
-
Santa Fé, Аргентина, S3000FFU
- ISIS Centro Especializado De Luce S.A.
-
-
-
-
-
Brussels, Бельгия, 1200
- Cliniques Universitaires Saint-Luc
-
Brussels, Бельгия, 1070
- Hôpital Erasme
-
Charleroi, Бельгия, 6000
- Le Grand Hôpital de Charleroi
-
La Louvière, Бельгия, 7100
- Centre Hospitalier Jolimont-Lobbes
-
-
-
-
-
Budapest, Венгрия, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
-
Budapest, Венгрия, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
-
Deszk, Венгрия, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
-
Pécs, Венгрия, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
-
Szekesfehervar, Венгрия, 8000
- Fejer Megyei Szent Gyorgy Korhaz
-
Szombathely, Венгрия, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
-
-
-
-
-
Bad Berka, Германия, 99437
- Zentralklinik Bad Berka
-
Berlin, Германия, 14165
- Helios Klinikum Emil von Behring GmbH
-
Bochum, Германия, 44791
- Augusta-Krankenanstalt Bochum
-
Coswig, Германия, 01640
- Fachkrankenhaus Coswig
-
Essen, Германия, 45122
- Universitaetsklinikum Essen
-
Frankfurt/Main, Германия, 60488
- Krankenhaus Nordwest
-
Freiburg, Германия, 79106
- Universitätsklinikum Freiburg
-
Großhansdorf, Германия, 22927
- LungenClinic Grosshansdorf
-
Göttingen, Германия, 37075
- Universitätsklinikum Göttingen
-
Halle (Saale), Германия, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
-
Hamburg, Германия, 21075
- Asklepios Klinik Harburg
-
Heidelberg, Германия, 69126
- Thoraxklinik Heidelberg
-
Hemer, Германия, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
-
Karlsruhe, Германия, 76137
- St. Vincentius-Kliniken Karlsruhe
-
Lübeck, Германия, 23538
- Universitaetsklinikum Schleswig-Holstein
-
Mainz, Германия, 55131
- Universitätsklinikum Mainz
-
Muenchen-Gauting, Германия, 82131
- Asklepios Klinikum Gauting
-
Oldenburg, Германия, 26121
- Pius Hospital Oldenburg
-
Villingen-Schwenningen, Германия, 78050
- Schwarzwald-Baar Klinikum
-
-
-
-
-
Athens, Греция, 15562
- IASO General Hospital of Athens
-
Thessaloniki, Греция, 54603
- "Papageorgiou" General Hospital of Thessaloniki
-
Thessaloniki, Греция, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
-
-
-
-
-
Madrid, Испания, 28041
- Hospital Universitario 12 De Octubre
-
Madrid, Испания, 28046
- Hospital Universitario La Paz
-
Madrid, Испания, 28033
- Hospital Oncologico MD Anderson
-
Málaga, Испания, 29010
- Hospital Carlos Haya
-
Málaga, Испания, 29010
- Hospital Clínico Virgen de la Victoria
-
Pamplona, Испания, 31008
- Clinica Universitaria de Navarra
-
Santander, Испания, 39008
- Hospital Universitario Marques de Valdecilla
-
Sevilla, Испания, 41700
- Hospital Universitario de Valme
-
Toledo, Испания, 45004
- Hospital Virgen de la Salud de Toledo
-
Valencia, Испания, 46014
- Hospital General Universitario de Valencia
-
-
Barcelona
-
L' Hospitalet de Llobregat, Barcelona, Испания, 08907
- ICO (Institut Catalá d´Oncología)
-
Manresa, Barcelona, Испания, 08243
- Fundacio Althaia
-
Sabadell, Barcelona, Испания, 08208
- Corporació Sanitària Parc Taulí
-
-
Madrid
-
Majadahonda, Madrid, Испания, 28222
- Hospital Puerta de Hierro Majadahonda
-
-
-
-
-
Ancona, Италия, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
-
Bologna, Италия, 40139
- Ospedale Bellaria
-
Catania, Италия, 95100
- Ospedale Garibaldi Nesima
-
Genova, Италия, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
-
Parma, Италия, 43100
- Azienda Ospedaliero- Universitaria di Parma
-
Perugia, Италия, 06132
- Ospedale S. Maria della Misericordia
-
Roma, Италия, 00152
- Azienda Ospedaliera San Camillo Forlanini
-
-
-
-
-
Toronto, Канада, M6R 1B5
- St. Joseph's Health Centre
-
-
Alberta
-
Edmonton, Alberta, Канада, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Kingston, Ontario, Канада, K7L 5P9
- Cancer Center of Southeastern Ontario at Kingston General Hospital
-
Mississauga, Ontario, Канада, L5M 2N1
- Trillium Health Partners - Credit Valley Hospital
-
Newmarket, Ontario, Канада, L3Y 2P9
- Stronach Regional cancer Centre at Southlake
-
Oshawa, Ontario, Канада, L1G 2B9
- RS MacLaughlin Durham Regional Cancer Centre
-
Sault Ste Marie, Ontario, Канада, P6A 5K7
- Sault Area Hospital
-
Thunder Bay, Ontario, Канада, P7B 6V4
- Thunder Bay Regional Health Science Centre
-
Toronto, Ontario, Канада, M5G 2C4
- Toronto General Hospital
-
-
Quebec
-
Montreal, Quebec, Канада, H3A 1A1
- Royal Victoria Hospital
-
Montreal, Quebec, Канада, H3G 1A4
- Montreal General Hospital
-
Montreal, Quebec, Канада, H2W 1S6
- McGill Dept. of Oncology
-
-
-
-
-
Gyeonggi-Do, Корея, Республика, 442-723
- Saint Vincent's Hospital
-
Incheon, Корея, Республика, 405-760
- Gachon Medical School Ghil Medical Center
-
Seoul, Корея, Республика, 138-736
- Asan Medical Center
-
Seoul, Корея, Республика, 110-744
- Seoul National University Hospital
-
Seoul, Корея, Республика, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
-
-
-
-
-
Lublin, Польша, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
-
Otwock, Польша, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
-
Poznan, Польша, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
-
Szczecin, Польша, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
-
Warsaw, Польша, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
-
Wroclaw, Польша, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
-
-
-
-
-
Arkhangelsk, Российская Федерация, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
-
Kemerovo, Российская Федерация, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
-
Krasnodar, Российская Федерация, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
-
Moscow, Российская Федерация, 105229
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
-
Moscow, Российская Федерация, 115478
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
-
Saint-Petersburg, Российская Федерация, 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, Российская Федерация, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
-
Saint-Petersburg, Российская Федерация, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
-
Tomsk, Российская Федерация, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
-
Yaroslavl, Российская Федерация, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
-
-
-
-
-
Bucuresti, Румыния, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
-
Bucuresti, Румыния, 022328
- Institutul Oncologic Al. Trestioreanu
-
Cluj-Napoca, Румыния, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
Iasi, Румыния, 700106
- Centrul de Oncologie Medicala
-
Sibiu, Румыния, 550245
- Spitalul Clinic Judetean Sibiu
-
-
Bihor
-
Oradea, Bihor, Румыния, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
-
-
Dolj
-
Craiova, Dolj, Румыния, 200535
- Oncoloab SRL
-
-
-
-
-
Birmingham, Соединенное Королевство, B9 5SS
- Birmingham Heartlands Hospital
-
Bristol, Соединенное Королевство, BS2 8ED
- Bristol Haematology and Oncology centre
-
Dundee, Соединенное Королевство, DD1 9SY
- Ninewells Hospital
-
Glasgow, Соединенное Королевство, G12 0YN
- Beatson West of Scotland Cancer Centre
-
Guildford, Соединенное Королевство, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
-
Lecester, Соединенное Королевство, LE1 5WW
- Leicester Royal Infirmary
-
Leeds, Соединенное Королевство, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
-
London, Соединенное Королевство, SE1 9RT
- Guy's Hospital
-
London, Соединенное Королевство, SW3 6JJ
- Royal Marsden Hospital
-
Sutton, Соединенное Королевство, SM2 5PT
- Royal Marsden Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, Соединенные Штаты, 35294
- University of Alabama at Birmingham
-
-
Arizona
-
Tucson, Arizona, Соединенные Штаты, 85724
- Arizona Cancer Center
-
-
Arkansas
-
Little Rock, Arkansas, Соединенные Штаты, 72205
- University of Arkansas for Medical Science
-
-
California
-
Beverly Hills, California, Соединенные Штаты, 90211
- Tower Cancer Research Foundation
-
Duarte, California, Соединенные Штаты, 91010
- City of Hope Nat'l Medical Center
-
Loma Linda, California, Соединенные Штаты, 92354
- Loma Linda University Medical Center
-
Los Angeles, California, Соединенные Штаты, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Соединенные Штаты, 90033
- USC/ Norris Comprehensive Cancer Center
-
Newport Beach, California, Соединенные Штаты, 92658
- Hoag Memorial Hospital Presbyterian
-
Palm Springs, California, Соединенные Штаты, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
-
Pleasant Hill, California, Соединенные Штаты, 94523
- Bay Area Cancer Research Group, LLC
-
San Francisco, California, Соединенные Штаты, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
-
South Pasadena, California, Соединенные Штаты, 91030
- City of Hope Medical Group (COHMG)
-
-
Colorado
-
Aurora, Colorado, Соединенные Штаты, 80045
- University of Colorado Hospital
-
Aurora, Colorado, Соединенные Штаты, 80012
- Rocky Mountain Cancer Center- Aurora
-
Boulder, Colorado, Соединенные Штаты, 80303
- Rocky Mountain Cancer Centers-Boulder
-
Colorado Springs, Colorado, Соединенные Штаты, 80907
- Rocky Mountain Cancer Center
-
Colorado Springs, Colorado, Соединенные Штаты, 80907
- Penrose St. Francis Health Services
-
Colorado Springs, Colorado, Соединенные Штаты, 80909
- Rocky Mountain Cancer Center
-
Denver, Colorado, Соединенные Штаты, 80218
- Rocky Mountain Cancer Center-Midtown
-
Denver, Colorado, Соединенные Штаты, 80220
- Rocky Mountain Cancer Centers- Rose
-
Lakewood, Colorado, Соединенные Штаты, 80228
- Rocky Mountain Cancer Centers
-
Littleton, Colorado, Соединенные Штаты, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Соединенные Штаты, 80124
- Rocky Mountain Cancer Center-Sky Ridge
-
Longmont, Colorado, Соединенные Штаты, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Parker, Colorado, Соединенные Штаты, 80138
- Rocky Mountain Cancer Center-Parker
-
Thornton, Colorado, Соединенные Штаты, 80260
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
New Haven, Connecticut, Соединенные Штаты, 06520
- Yale University
-
Sharon, Connecticut, Соединенные Штаты, 06069
- Smilow Cancer Hospital Care Center
-
Stamford, Connecticut, Соединенные Штаты, 06902
- Hematology Oncology, P.C.
-
Torrington, Connecticut, Соединенные Штаты, 06790
- Smilow Cancer Hospital Care Center
-
-
Florida
-
Hudson, Florida, Соединенные Штаты, 34667
- Florida Cancer Institute-New Hope
-
Jacksonville, Florida, Соединенные Штаты, 32204
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Соединенные Штаты, 32216
- Cancer Specialists of North Florida
-
Lakeland, Florida, Соединенные Штаты, 33805
- Watson Clinic LLP
-
Miami, Florida, Соединенные Штаты, 33176
- Advanced Medical Specialties
-
New Port Richey, Florida, Соединенные Штаты, 34655
- Florida Cancer Institute- New Hope
-
Orlando, Florida, Соединенные Штаты, 32806
- Florida Cancer Specialists
-
Port St. Lucie, Florida, Соединенные Штаты, 34952
- Hematology Oncology Associates of the Treasure Coast
-
-
Georgia
-
Atlanta, Georgia, Соединенные Штаты, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
-
Macon, Georgia, Соединенные Штаты, 31201
- Central Georgia Cancer Care, PC
-
Marietta, Georgia, Соединенные Штаты, 30060
- Northwest Georgia Oncology Centers, PC
-
-
Idaho
-
Boise, Idaho, Соединенные Штаты, 83712
- Mountain States Tumor Institute
-
Meridian, Idaho, Соединенные Штаты, 83642
- Mountain States Tumor Institute
-
Post Falls, Idaho, Соединенные Штаты, 83854
- Kootenai Cancer Center
-
Twin Falls, Idaho, Соединенные Штаты, 83301
- Mountain States Tumor Institute
-
-
Illinois
-
Chicago, Illinois, Соединенные Штаты, 60612
- Rush University Medical Center
-
Chicago, Illinois, Соединенные Штаты, 60637
- University of Chicago, Section of Hematology/Oncology
-
Joliet, Illinois, Соединенные Штаты, 60435
- Joliet Oncology Hematology Assoc., LTD
-
Maywood, Illinois, Соединенные Штаты, 60153
- Loyola University Medical Center
-
-
Indiana
-
Carmel, Indiana, Соединенные Штаты, 46032
- Indiana University Health
-
Fishers, Indiana, Соединенные Штаты, 46037
- Indiana University Health
-
Greenfield, Indiana, Соединенные Штаты, 46140
- Indiana University Health
-
Indianapolis, Indiana, Соединенные Штаты, 46219
- Indiana University Health
-
Indianapolis, Indiana, Соединенные Штаты, 46227
- Indiana University Health
-
-
Kansas
-
Westwood, Kansas, Соединенные Штаты, 66205
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Соединенные Штаты, 40202
- Norton Healthcare, Inc.
-
-
Louisiana
-
Houma, Louisiana, Соединенные Штаты, 70363
- Leonard J. Chabert Medical Center
-
-
Maine
-
Brewer, Maine, Соединенные Штаты, 04412
- Cancer Care of Maine
-
-
Maryland
-
Baltimore, Maryland, Соединенные Штаты, 21204
- Greater Baltimore Medical Center
-
Towson, Maryland, Соединенные Штаты, 21204
- St. Joseph Medical Center's Cancer Institute
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02135
- Caritas St. Elizabeth's Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Соединенные Штаты, 48106
- St. Joseph Mercy Hospital
-
-
Minnesota
-
Burnsville, Minnesota, Соединенные Штаты, 55337
- Minnesota Oncology Hematology, P.A.
-
Edina, Minnesota, Соединенные Штаты, 55435-2150
- Minnesota Oncology Hematology, P.A.
-
Maplewood, Minnesota, Соединенные Штаты, 55109
- Minnesota Oncology Hematology, P.A.
-
Minneapolis, Minnesota, Соединенные Штаты, 55404
- Minnesota Oncology Hematology, P.A.
-
St. Paul, Minnesota, Соединенные Штаты, 55102-2389
- Minnesota Oncology Hematology
-
Woodbury, Minnesota, Соединенные Штаты, 55125
- Minnesota Oncology Hematology, P.A.
-
-
Missouri
-
Columbia, Missouri, Соединенные Штаты, 65201
- Missouri Cancer Associates
-
St. Joseph, Missouri, Соединенные Штаты, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
-
-
Nebraska
-
Grand Island, Nebraska, Соединенные Штаты, 68803
- St. Francis Cancer Treatment Center
-
Omaha, Nebraska, Соединенные Штаты, 68114
- Nebraska Methodist Hospital
-
-
Nevada
-
Henderson, Nevada, Соединенные Штаты, 89052
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Соединенные Штаты, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Соединенные Штаты, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Соединенные Штаты, 89169
- Comprehensive Cancer Centers of Nevada
-
-
New Hampshire
-
Concord, New Hampshire, Соединенные Штаты, 03301
- NH Oncology-Hematology PA (Co)
-
Hooksett, New Hampshire, Соединенные Штаты, 03106
- NH Oncology-Hematology PA
-
Lebanon, New Hampshire, Соединенные Штаты, 03756
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Соединенные Штаты, 07601
- Hackensack University Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Соединенные Штаты, 87131
- University of New Mexico Health Science Center
-
Santa Fe, New Mexico, Соединенные Штаты, 87505
- Christus St. Vincent Regional Cancer Center
-
-
New York
-
Brockport, New York, Соединенные Штаты, 14420
- Interlakes Oncology Hematology, PC
-
Bronx, New York, Соединенные Штаты, 10467
- Montefiore Medical Center
-
Canadaigua, New York, Соединенные Штаты, 14424
- Interlakes Oncology Hematology, PC
-
Geneva, New York, Соединенные Штаты, 14456
- Interlakes Oncology Hematology, PC
-
New Rochelle, New York, Соединенные Штаты, 10801
- Advanced Oncology Associates
-
New York, New York, Соединенные Штаты, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
-
Rochester, New York, Соединенные Штаты, 14623
- Interlakes Oncology Hematology, PC
-
Rochester, New York, Соединенные Штаты, 14626
- Interlakes Oncology Hematology, PC
-
Stony Brook, New York, Соединенные Штаты, 11794
- Stony Brook University Medical Center
-
-
North Carolina
-
Cary, North Carolina, Соединенные Штаты, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
-
Hickory, North Carolina, Соединенные Штаты, 28602
- Carolina Oncology Specialists PA
-
Raleigh, North Carolina, Соединенные Штаты, 27607
- Raleigh Hematology Oncology Associates
-
Raleigh, North Carolina, Соединенные Штаты, 27609
- Raleigh Hematology Oncology Associates
-
-
Ohio
-
Canton, Ohio, Соединенные Штаты, 44710
- Aultman Hospital/ North Canton Medical Foundation
-
Cleveland, Ohio, Соединенные Штаты, 44106
- University Hopsitals of Cleveland
-
Columbus, Ohio, Соединенные Штаты, 43228
- Hematology Oncology Consultants Inc.
-
-
Oregon
-
Portland, Oregon, Соединенные Штаты, 97213
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Соединенные Штаты, 97225
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Соединенные Штаты, 97227
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Соединенные Штаты, 97213
- Earle A Chiles Research Institute
-
Tualatin, Oregon, Соединенные Штаты, 97062
- Northwest Cancer Specialists, PC
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Соединенные Штаты, 18015
- Cancer Care Associates - Medical Oncology
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- The Hospital of the University of Pennsylvania
-
Pittsburg, Pennsylvania, Соединенные Штаты, 15212
- Allegheny General Hospital
-
-
South Carolina
-
Columbia, South Carolina, Соединенные Штаты, 29210
- South Carolina Oncology Assoc., PA
-
Easley, South Carolina, Соединенные Штаты, 29640
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Соединенные Штаты, 29605
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Соединенные Штаты, 29615
- Cancer Centers of the Carolinas
-
Seneca, South Carolina, Соединенные Штаты, 29672
- Cancer Centers of the Carolinas, Seneca
-
Spartanburg, South Carolina, Соединенные Штаты, 29307
- Cancer Centers of the Carolinas
-
-
Tennessee
-
Cookeville, Tennessee, Соединенные Штаты, 38501
- Cookeville Regional Medical Center
-
Germantown, Tennessee, Соединенные Штаты, 38138
- Bostin Baskin Cancer Foundation
-
Knoxville, Tennessee, Соединенные Штаты, 37909
- Tennessee Cancer Specialists
-
Memphis, Tennessee, Соединенные Штаты, 38120
- West Clinic
-
Memphis, Tennessee, Соединенные Штаты, 38119
- Family Cancer Center Foundation, Inc.
-
Memphis, Tennessee, Соединенные Штаты, 38104
- Bostin Baskin Cancer Foundation
-
Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Cancer Center
-
Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Amarillo, Texas, Соединенные Штаты, 79106
- Texas Oncology, P.A. - Amarillo
-
Beaumont, Texas, Соединенные Штаты, 77702-1449
- Texas Oncology Beaumont
-
Dallas, Texas, Соединенные Штаты, 75246
- Baylor Charles A Sammons Cancer Center
-
Dallas, Texas, Соединенные Штаты, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
-
Flower Mound, Texas, Соединенные Штаты, 75028
- Texas Oncology - Flower Mound
-
Fort Worth, Texas, Соединенные Штаты, 76132
- Texas Oncology Southwest Forth Worth
-
Ft. Worth, Texas, Соединенные Штаты, 76104
- Texas Oncology, Fort Worth
-
Garland, Texas, Соединенные Штаты, 75042-5788
- Texas Oncology, Garland
-
New Braunfels, Texas, Соединенные Штаты, 78131
- Cancer Care Centers of South Texas - HOAST
-
Paris, Texas, Соединенные Штаты, 75460-5004
- Texas Oncology - Paris
-
Plano, Texas, Соединенные Штаты, 75075-7787
- Texas Oncology - Plano East
-
San Antonio, Texas, Соединенные Штаты, 78229
- Cancer Care Centers of South Texas-HOAST
-
Tyler, Texas, Соединенные Штаты, 75702
- Texas Oncology -Tyler
-
Waco, Texas, Соединенные Штаты, 76712
- Texas Oncology Cancer Care and Research Center
-
-
Virginia
-
Christiansburg, Virginia, Соединенные Штаты, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Christiansburg, Virginia, Соединенные Штаты, 24073
- Onc and Hem Associates of SW VA, Inc.
-
Hampton, Virginia, Соединенные Штаты, 23666
- Virginia Oncology Associates
-
Newport News, Virginia, Соединенные Штаты, 23606
- Virginia Oncology Associates
-
Norfolk, Virginia, Соединенные Штаты, 23502
- Virginia Oncology Associates
-
Roanoke, Virginia, Соединенные Штаты, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Salem, Virginia, Соединенные Штаты, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
-
Wytheville, Virginia, Соединенные Штаты, 24382
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
-
Washington
-
Seattle, Washington, Соединенные Штаты, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
-
Spokane, Washington, Соединенные Штаты, 99218
- Cancer Care Northwest-North
-
Spokane, Washington, Соединенные Штаты, 99202
- Cancer Care Northwest
-
Spokane Valley, Washington, Соединенные Штаты, 99216
- Cancer Care Northwest-Valley
-
Vancouver, Washington, Соединенные Штаты, 98684
- Northwest Cancer Specialists, P.C.
-
Vancouver, Washington, Соединенные Штаты, 98686
- Northwest Cancer Specialist, P.C.
-
-
-
-
-
Changhua, Тайвань, 500-06
- Changhua Christian Hospital
-
Kaohsiung, Тайвань, 833
- Chang Gung Medical Foundation
-
Taichung, Тайвань, 404
- China Medical University Hospital
-
Taichung, Тайвань, 402
- Chung Shan Medical University Hospital
-
Taichung, Тайвань, 407
- Taichung Veterans General Hospital
-
Taipei, Тайвань, 112
- Taipei Veterans General Hospital
-
Taoyuan, Тайвань, 333
- Chang Gung memorial hospital
-
-
-
-
-
Bayonne, Франция, 64100
- Centre d'oncologie et de radiothérapie du Pays Basque
-
Brest cedex, Франция, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
-
Caen Cedex, Франция, 14033
- CHU de Caen - Service de pneumologie
-
Clermont-Ferrand cedex 1, Франция, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
-
Lyon cedex 04, Франция, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
-
Marseille cedex 9, Франция, 13273
- Institut Paoli-Calmettes
-
PARIS cedex 14, Франция, 75014
- Fondation Hôpital Saint Joseph
-
Paris, Франция, 75012
- Hôpital de Tenon
-
Perpignan, Франция, 66000
- Centre Catalan d'Oncologie
-
Rennes cedex 9, Франция, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
-
Saint Priest en Jarez, Франция, 42271
- Institut de Cancerologie de La Loire
-
Vandoeuvre-lès-Nancy Cedex, Франция, 54511
- Hôpital de Brabois
-
-
Cedex 9
-
Toulouse, Cedex 9, Франция, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
-
-
-
-
-
Ceske Budejovice, Чешская Республика, 370 87
- Nemocnice Ceske Budejovice, a.s.
-
Ostrava-Poruba, Чешская Республика, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
-
Praha, Чешская Республика, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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
Другие имена:
|
|
Плацебо Компаратор: 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.
|
Таблетка плацебо
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Disease Free Survival (DFS)
Временное ограничение: 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)
Временное ограничение: 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).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival (OS)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 сентября 2006 г.
Первичное завершение (Действительный)
1 апреля 2013 г.
Завершение исследования (Действительный)
1 июня 2014 г.
Даты регистрации исследования
Первый отправленный
7 сентября 2006 г.
Впервые представлено, что соответствует критериям контроля качества
7 сентября 2006 г.
Первый опубликованный (Оценивать)
8 сентября 2006 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
17 сентября 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 сентября 2015 г.
Последняя проверка
1 сентября 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Новообразования
- Легочные заболевания
- Новообразования по локализации
- Новообразования дыхательных путей
- Грудные новообразования
- Рак, Бронхогенный
- Бронхиальные новообразования
- Новообразования легких
- Карцинома немелкоклеточного легкого
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Противоопухолевые агенты
- Ингибиторы протеинкиназы
- Эрлотиниб гидрохлорид
Другие идентификационные номера исследования
- OSI-774-302
- 2005-001747-29 (Номер EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Плацебо
-
University of FloridaЗавершенныйАпноэ сна, обструктивное | ХрапСоединенные Штаты
-
Centre Hospitalier Universitaire de Saint EtienneЗавершенный
-
PfizerЗавершенныйАтопический дерматитКитай, Япония, Корея, Республика
-
Tasly Pharmaceutical Group Co., LtdНеизвестныйСиндром раздраженного кишечника с диареейКитай
-
Guang'anmen Hospital of China Academy of Chinese...НеизвестныйИшемическая болезнь сердца | Нестабильная стенокардия | Синдром застоя кровиКитай
-
University Hospital, Clermont-FerrandРекрутингОральный мукозитФранция
-
Henan University of Traditional Chinese MedicineJiangsu Province Hospital of Traditional Chinese MedicineНеизвестныйХроническое обструктивное заболевание легкихКитай
-
Universidad Francisco de VitoriaЗавершенныйПищевая добавка | Спортивная производительностьИспания
-
TakedaЗавершенныйХроническая бессонницаСоединенные Штаты
-
TakedaЗавершенныйХроническая бессонница