- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00373425
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)
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
-
Buenos Aires, Argentinien, C1181ACH
- Hospital Italiano de Buenos Aires
-
Buenos Aires, Argentinien, C1272AAA
- Hospital de Rehabilitación Respiratoria María Ferrer
-
Mendoza, Argentinien, M5500AYB
- COIR
-
Rosario, Santa Fe, Argentinien, S2001SBL
- Hospital Espanol de Rosario
-
Santa Fé, Argentinien, S3000FFU
- ISIS Centro Especializado De Luce S.A.
-
-
-
-
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Adelaide, Australien, 5067
- Respiratory Clinical Trials Pty., Ltd
-
Ashford, Australien, SA 5037
- Ashford Cancer Centre
-
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New South Wales
-
Campbelltown, New South Wales, Australien, 2560
- Campbelltown Hospital
-
Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
-
St Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital
-
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Victoria
-
East Bentleigh, Victoria, Australien, 3165
- Monash Medical Centre
-
Fitzroy, Victoria, Australien, 3065
- St Vincent's Hospital Melbourne
-
Heidelberg, Victoria, Australien, 3084
- Austin Hospital
-
-
-
-
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Brussels, Belgien, 1200
- Cliniques universitaires Saint-Luc
-
Brussels, Belgien, 1070
- Hopital Erasme
-
Charleroi, Belgien, 6000
- Le Grand Hôpital de Charleroi
-
La Louvière, Belgien, 7100
- Centre Hospitalier Jolimont-Lobbes
-
-
-
-
-
Bad Berka, Deutschland, 99437
- Zentralklinik Bad Berka
-
Berlin, Deutschland, 14165
- Helios Klinikum Emil von Behring GmbH
-
Bochum, Deutschland, 44791
- Augusta-Krankenanstalt Bochum
-
Coswig, Deutschland, 01640
- Fachkrankenhaus Coswig
-
Essen, Deutschland, 45122
- Universitaetsklinikum Essen
-
Frankfurt/Main, Deutschland, 60488
- Krankenhaus Nordwest
-
Freiburg, Deutschland, 79106
- Universitätsklinikum Freiburg
-
Großhansdorf, Deutschland, 22927
- LungenClinic Großhansdorf
-
Göttingen, Deutschland, 37075
- Universitätsklinikum Göttingen
-
Halle (Saale), Deutschland, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
-
Hamburg, Deutschland, 21075
- Asklepios Klinik Harburg
-
Heidelberg, Deutschland, 69126
- Thoraxklinik Heidelberg
-
Hemer, Deutschland, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
-
Karlsruhe, Deutschland, 76137
- St. Vincentius-Kliniken Karlsruhe
-
Lübeck, Deutschland, 23538
- Universitaetsklinikum Schleswig-Holstein
-
Mainz, Deutschland, 55131
- Universitätsklinikum Mainz
-
Muenchen-Gauting, Deutschland, 82131
- Asklepios Klinikum Gauting
-
Oldenburg, Deutschland, 26121
- Pius Hospital Oldenburg
-
Villingen-Schwenningen, Deutschland, 78050
- Schwarzwald-Baar Klinikum
-
-
-
-
-
Bayonne, Frankreich, 64100
- Centre d'oncologie et de radiothérapie du Pays Basque
-
Brest cedex, Frankreich, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
-
Caen Cedex, Frankreich, 14033
- CHU de Caen - Service de pneumologie
-
Clermont-Ferrand cedex 1, Frankreich, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
-
Lyon cedex 04, Frankreich, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
-
Marseille cedex 9, Frankreich, 13273
- Institut Paoli-Calmettes
-
PARIS cedex 14, Frankreich, 75014
- Fondation Hôpital Saint Joseph
-
Paris, Frankreich, 75012
- Hôpital de Tenon
-
Perpignan, Frankreich, 66000
- Centre Catalan d'Oncologie
-
Rennes cedex 9, Frankreich, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
-
Saint Priest en Jarez, Frankreich, 42271
- Institut de Cancérologie de la Loire
-
Vandoeuvre-lès-Nancy Cedex, Frankreich, 54511
- Hôpital de Brabois
-
-
Cedex 9
-
Toulouse, Cedex 9, Frankreich, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
-
-
-
-
-
Athens, Griechenland, 15562
- IASO General Hospital of Athens
-
Thessaloniki, Griechenland, 54603
- "Papageorgiou" General Hospital of Thessaloniki
-
Thessaloniki, Griechenland, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
-
-
-
-
-
Ancona, Italien, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
-
Bologna, Italien, 40139
- Ospedale Bellaria
-
Catania, Italien, 95100
- Ospedale Garibaldi Nesima
-
Genova, Italien, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
-
Parma, Italien, 43100
- Azienda Ospedaliero- Universitaria di Parma
-
Perugia, Italien, 06132
- Ospedale S. Maria Della Misericordia
-
Roma, Italien, 00152
- Azienda Ospedaliera San Camillo Forlanini
-
-
-
-
-
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
-
-
-
-
-
Gyeonggi-Do, Korea, Republik von, 442-723
- Saint Vincent's Hospital
-
Incheon, Korea, Republik von, 405-760
- Gachon Medical School Ghil Medical Center
-
Seoul, Korea, Republik von, 138-736
- Asan Medical Center
-
Seoul, Korea, Republik von, 110-744
- Seoul National University Hospital
-
Seoul, Korea, Republik von, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
-
-
-
-
-
Lublin, Polen, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
-
Otwock, Polen, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
-
Poznan, Polen, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
-
Szczecin, Polen, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
-
Warsaw, Polen, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
-
Wroclaw, Polen, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
-
-
-
-
-
Bucuresti, Rumänien, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
-
Bucuresti, Rumänien, 022328
- Institutul Oncologic Al. Trestioreanu
-
Cluj-Napoca, Rumänien, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
-
Iasi, Rumänien, 700106
- Centrul de Oncologie Medicala
-
Sibiu, Rumänien, 550245
- Spitalul Clinic Judetean Sibiu
-
-
Bihor
-
Oradea, Bihor, Rumänien, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
-
-
Dolj
-
Craiova, Dolj, Rumänien, 200535
- Oncoloab SRL
-
-
-
-
-
Arkhangelsk, Russische Föderation, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
-
Kemerovo, Russische Föderation, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
-
Krasnodar, Russische Föderation, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
-
Moscow, Russische Föderation, 105229
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
-
Moscow, Russische Föderation, 115478
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
-
Saint-Petersburg, Russische Föderation, 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, Russische Föderation, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
-
Saint-Petersburg, Russische Föderation, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
-
Tomsk, Russische Föderation, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
-
Yaroslavl, Russische Föderation, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
-
-
-
-
-
Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Madrid, Spanien, 28033
- Hospital Oncologico MD Anderson
-
Málaga, Spanien, 29010
- Hospital Carlos Haya
-
Málaga, Spanien, 29010
- Hospital Clínico Virgen de la Victoria
-
Pamplona, Spanien, 31008
- Clinica Universitaria de Navarra
-
Santander, Spanien, 39008
- Hospital Universitario Marqués de Valdecilla
-
Sevilla, Spanien, 41700
- Hospital Universitario de Valme
-
Toledo, Spanien, 45004
- Hospital Virgen de la Salud de Toledo
-
Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
-
-
Barcelona
-
L' Hospitalet de Llobregat, Barcelona, Spanien, 08907
- ICO (Institut Catalá d´Oncología)
-
Manresa, Barcelona, Spanien, 08243
- Fundacio Althaia
-
Sabadell, Barcelona, Spanien, 08208
- Corporacio Sanitaria Parc Tauli
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Hospital Puerta de Hierro Majadahonda
-
-
-
-
-
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
-
-
-
-
-
Ceske Budejovice, Tschechische Republik, 370 87
- Nemocnice Ceske Budejovice, a.s.
-
Ostrava-Poruba, Tschechische Republik, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
-
Praha, Tschechische Republik, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
-
-
-
-
-
Budapest, Ungarn, 1121
- Orszagos Koranyi TBC es Pulmonologiai Intezet
-
Budapest, Ungarn, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
-
Deszk, Ungarn, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
-
Pécs, Ungarn, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
-
Szekesfehervar, Ungarn, 8000
- Fejer Megyei Szent Gyorgy Korhaz
-
Szombathely, Ungarn, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
-
-
-
-
Alabama
-
Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama at Birmingham
-
-
Arizona
-
Tucson, Arizona, Vereinigte Staaten, 85724
- Arizona Cancer Center
-
-
Arkansas
-
Little Rock, Arkansas, Vereinigte Staaten, 72205
- University of Arkansas for Medical Science
-
-
California
-
Beverly Hills, California, Vereinigte Staaten, 90211
- Tower Cancer Research Foundation
-
Duarte, California, Vereinigte Staaten, 91010
- City of Hope Nat'l Medical Center
-
Loma Linda, California, Vereinigte Staaten, 92354
- Loma Linda University Medical Center
-
Los Angeles, California, Vereinigte Staaten, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Vereinigte Staaten, 90033
- USC/ Norris Comprehensive Cancer Center
-
Newport Beach, California, Vereinigte Staaten, 92658
- Hoag Memorial Hospital Presbyterian
-
Palm Springs, California, Vereinigte Staaten, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
-
Pleasant Hill, California, Vereinigte Staaten, 94523
- Bay Area Cancer Research Group, LLC
-
San Francisco, California, Vereinigte Staaten, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
-
South Pasadena, California, Vereinigte Staaten, 91030
- City of Hope Medical Group (COHMG)
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Hospital
-
Aurora, Colorado, Vereinigte Staaten, 80012
- Rocky Mountain Cancer Center- Aurora
-
Boulder, Colorado, Vereinigte Staaten, 80303
- Rocky Mountain Cancer Centers-Boulder
-
Colorado Springs, Colorado, Vereinigte Staaten, 80907
- Rocky Mountain Cancer Center
-
Colorado Springs, Colorado, Vereinigte Staaten, 80907
- Penrose St. Francis Health Services
-
Colorado Springs, Colorado, Vereinigte Staaten, 80909
- Rocky Mountain Cancer Center
-
Denver, Colorado, Vereinigte Staaten, 80218
- Rocky Mountain Cancer Center-Midtown
-
Denver, Colorado, Vereinigte Staaten, 80220
- Rocky Mountain Cancer Centers- Rose
-
Lakewood, Colorado, Vereinigte Staaten, 80228
- Rocky Mountain Cancer Centers
-
Littleton, Colorado, Vereinigte Staaten, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Vereinigte Staaten, 80124
- Rocky Mountain Cancer Center-Sky Ridge
-
Longmont, Colorado, Vereinigte Staaten, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Parker, Colorado, Vereinigte Staaten, 80138
- Rocky Mountain Cancer Center-Parker
-
Thornton, Colorado, Vereinigte Staaten, 80260
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06520
- Yale University
-
Sharon, Connecticut, Vereinigte Staaten, 06069
- Smilow Cancer Hospital Care Center
-
Stamford, Connecticut, Vereinigte Staaten, 06902
- Hematology Oncology, P.C.
-
Torrington, Connecticut, Vereinigte Staaten, 06790
- Smilow Cancer Hospital Care Center
-
-
Florida
-
Hudson, Florida, Vereinigte Staaten, 34667
- Florida Cancer Institute-New Hope
-
Jacksonville, Florida, Vereinigte Staaten, 32204
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Vereinigte Staaten, 32216
- Cancer Specialists of North Florida
-
Lakeland, Florida, Vereinigte Staaten, 33805
- Watson Clinic LLP
-
Miami, Florida, Vereinigte Staaten, 33176
- Advanced Medical Specialties
-
New Port Richey, Florida, Vereinigte Staaten, 34655
- Florida Cancer Institute- New Hope
-
Orlando, Florida, Vereinigte Staaten, 32806
- Florida Cancer Specialists
-
Port St. Lucie, Florida, Vereinigte Staaten, 34952
- Hematology Oncology Associates of the Treasure Coast
-
-
Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
-
Macon, Georgia, Vereinigte Staaten, 31201
- Central Georgia Cancer Care, PC
-
Marietta, Georgia, Vereinigte Staaten, 30060
- Northwest Georgia Oncology Centers, PC
-
-
Idaho
-
Boise, Idaho, Vereinigte Staaten, 83712
- Mountain States Tumor Institute
-
Meridian, Idaho, Vereinigte Staaten, 83642
- Mountain States Tumor Institute
-
Post Falls, Idaho, Vereinigte Staaten, 83854
- Kootenai Cancer Center
-
Twin Falls, Idaho, Vereinigte Staaten, 83301
- Mountain States Tumor Institute
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60612
- Rush University Medical Center
-
Chicago, Illinois, Vereinigte Staaten, 60637
- University of Chicago, Section of Hematology/Oncology
-
Joliet, Illinois, Vereinigte Staaten, 60435
- Joliet Oncology Hematology Assoc., LTD
-
Maywood, Illinois, Vereinigte Staaten, 60153
- Loyola University Medical Center
-
-
Indiana
-
Carmel, Indiana, Vereinigte Staaten, 46032
- Indiana University Health
-
Fishers, Indiana, Vereinigte Staaten, 46037
- Indiana University Health
-
Greenfield, Indiana, Vereinigte Staaten, 46140
- Indiana University Health
-
Indianapolis, Indiana, Vereinigte Staaten, 46219
- Indiana University Health
-
Indianapolis, Indiana, Vereinigte Staaten, 46227
- Indiana University Health
-
-
Kansas
-
Westwood, Kansas, Vereinigte Staaten, 66205
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Vereinigte Staaten, 40202
- Norton Healthcare, Inc.
-
-
Louisiana
-
Houma, Louisiana, Vereinigte Staaten, 70363
- Leonard J. Chabert Medical Center
-
-
Maine
-
Brewer, Maine, Vereinigte Staaten, 04412
- Cancer Care of Maine
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21204
- Greater Baltimore Medical Center
-
Towson, Maryland, Vereinigte Staaten, 21204
- St. Joseph Medical Center's Cancer Institute
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02135
- Caritas St. Elizabeth's Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Vereinigte Staaten, 48106
- St. Joseph Mercy Hospital
-
-
Minnesota
-
Burnsville, Minnesota, Vereinigte Staaten, 55337
- Minnesota Oncology Hematology, P.A.
-
Edina, Minnesota, Vereinigte Staaten, 55435-2150
- Minnesota Oncology Hematology, P.A.
-
Maplewood, Minnesota, Vereinigte Staaten, 55109
- Minnesota Oncology Hematology, P.A.
-
Minneapolis, Minnesota, Vereinigte Staaten, 55404
- Minnesota Oncology Hematology, P.A.
-
St. Paul, Minnesota, Vereinigte Staaten, 55102-2389
- Minnesota Oncology Hematology
-
Woodbury, Minnesota, Vereinigte Staaten, 55125
- Minnesota Oncology Hematology, P.A.
-
-
Missouri
-
Columbia, Missouri, Vereinigte Staaten, 65201
- Missouri Cancer Associates
-
St. Joseph, Missouri, Vereinigte Staaten, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
-
-
Nebraska
-
Grand Island, Nebraska, Vereinigte Staaten, 68803
- St. Francis Cancer Treatment Center
-
Omaha, Nebraska, Vereinigte Staaten, 68114
- Nebraska Methodist Hospital
-
-
Nevada
-
Henderson, Nevada, Vereinigte Staaten, 89052
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89169
- Comprehensive Cancer Centers of Nevada
-
-
New Hampshire
-
Concord, New Hampshire, Vereinigte Staaten, 03301
- NH Oncology-Hematology PA (Co)
-
Hooksett, New Hampshire, Vereinigte Staaten, 03106
- NH Oncology-Hematology PA
-
Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Vereinigte Staaten, 07601
- Hackensack University Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Vereinigte Staaten, 87131
- University of New Mexico Health Science Center
-
Santa Fe, New Mexico, Vereinigte Staaten, 87505
- Christus St. Vincent Regional Cancer Center
-
-
New York
-
Brockport, New York, Vereinigte Staaten, 14420
- Interlakes Oncology Hematology, PC
-
Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center
-
Canadaigua, New York, Vereinigte Staaten, 14424
- Interlakes Oncology Hematology, PC
-
Geneva, New York, Vereinigte Staaten, 14456
- Interlakes Oncology Hematology, PC
-
New Rochelle, New York, Vereinigte Staaten, 10801
- Advanced Oncology Associates
-
New York, New York, Vereinigte Staaten, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
-
Rochester, New York, Vereinigte Staaten, 14623
- Interlakes Oncology Hematology, PC
-
Rochester, New York, Vereinigte Staaten, 14626
- Interlakes Oncology Hematology, PC
-
Stony Brook, New York, Vereinigte Staaten, 11794
- Stony Brook University Medical Center
-
-
North Carolina
-
Cary, North Carolina, Vereinigte Staaten, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
-
Hickory, North Carolina, Vereinigte Staaten, 28602
- Carolina Oncology Specialists PA
-
Raleigh, North Carolina, Vereinigte Staaten, 27607
- Raleigh Hematology Oncology Associates
-
Raleigh, North Carolina, Vereinigte Staaten, 27609
- Raleigh Hematology Oncology Associates
-
-
Ohio
-
Canton, Ohio, Vereinigte Staaten, 44710
- Aultman Hospital/ North Canton Medical Foundation
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- University Hopsitals of Cleveland
-
Columbus, Ohio, Vereinigte Staaten, 43228
- Hematology Oncology Consultants Inc.
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97213
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Vereinigte Staaten, 97225
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Vereinigte Staaten, 97227
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Vereinigte Staaten, 97213
- Earle A Chiles Research Institute
-
Tualatin, Oregon, Vereinigte Staaten, 97062
- Northwest Cancer Specialists, PC
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Vereinigte Staaten, 18015
- Cancer Care Associates - Medical Oncology
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- The Hospital of the University of Pennsylvania
-
Pittsburg, Pennsylvania, Vereinigte Staaten, 15212
- Allegheny General Hospital
-
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South Carolina
-
Columbia, South Carolina, Vereinigte Staaten, 29210
- South Carolina Oncology Assoc., PA
-
Easley, South Carolina, Vereinigte Staaten, 29640
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Vereinigte Staaten, 29605
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Vereinigte Staaten, 29615
- Cancer Centers of the Carolinas
-
Seneca, South Carolina, Vereinigte Staaten, 29672
- Cancer Centers of the Carolinas, Seneca
-
Spartanburg, South Carolina, Vereinigte Staaten, 29307
- Cancer Centers of the Carolinas
-
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Tennessee
-
Cookeville, Tennessee, Vereinigte Staaten, 38501
- Cookeville Regional Medical Center
-
Germantown, Tennessee, Vereinigte Staaten, 38138
- Bostin Baskin Cancer Foundation
-
Knoxville, Tennessee, Vereinigte Staaten, 37909
- Tennessee Cancer Specialists
-
Memphis, Tennessee, Vereinigte Staaten, 38120
- West Clinic
-
Memphis, Tennessee, Vereinigte Staaten, 38119
- Family Cancer Center Foundation, Inc.
-
Memphis, Tennessee, Vereinigte Staaten, 38104
- Bostin Baskin Cancer Foundation
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Sarah Cannon Cancer Center
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Amarillo, Texas, Vereinigte Staaten, 79106
- Texas Oncology, P.A. - Amarillo
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Beaumont, Texas, Vereinigte Staaten, 77702-1449
- Texas Oncology Beaumont
-
Dallas, Texas, Vereinigte Staaten, 75246
- Baylor Charles A Sammons Cancer Center
-
Dallas, Texas, Vereinigte Staaten, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
-
Flower Mound, Texas, Vereinigte Staaten, 75028
- Texas Oncology - Flower Mound
-
Fort Worth, Texas, Vereinigte Staaten, 76132
- Texas Oncology Southwest Forth Worth
-
Ft. Worth, Texas, Vereinigte Staaten, 76104
- Texas Oncology, Fort Worth
-
Garland, Texas, Vereinigte Staaten, 75042-5788
- Texas Oncology, Garland
-
New Braunfels, Texas, Vereinigte Staaten, 78131
- Cancer Care Centers of South Texas - HOAST
-
Paris, Texas, Vereinigte Staaten, 75460-5004
- Texas Oncology - Paris
-
Plano, Texas, Vereinigte Staaten, 75075-7787
- Texas Oncology - Plano East
-
San Antonio, Texas, Vereinigte Staaten, 78229
- Cancer Care Centers of South Texas-HOAST
-
Tyler, Texas, Vereinigte Staaten, 75702
- Texas Oncology -Tyler
-
Waco, Texas, Vereinigte Staaten, 76712
- Texas Oncology Cancer Care and Research Center
-
-
Virginia
-
Christiansburg, Virginia, Vereinigte Staaten, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Christiansburg, Virginia, Vereinigte Staaten, 24073
- Onc and Hem Associates of SW VA, Inc.
-
Hampton, Virginia, Vereinigte Staaten, 23666
- Virginia Oncology Associates
-
Newport News, Virginia, Vereinigte Staaten, 23606
- Virginia Oncology Associates
-
Norfolk, Virginia, Vereinigte Staaten, 23502
- Virginia Oncology Associates
-
Roanoke, Virginia, Vereinigte Staaten, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Salem, Virginia, Vereinigte Staaten, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
-
Wytheville, Virginia, Vereinigte Staaten, 24382
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
-
Spokane, Washington, Vereinigte Staaten, 99218
- Cancer Care Northwest-North
-
Spokane, Washington, Vereinigte Staaten, 99202
- Cancer Care Northwest
-
Spokane Valley, Washington, Vereinigte Staaten, 99216
- Cancer Care Northwest-Valley
-
Vancouver, Washington, Vereinigte Staaten, 98684
- Northwest Cancer Specialists, P.C.
-
Vancouver, Washington, Vereinigte Staaten, 98686
- Northwest Cancer Specialist, P.C.
-
-
-
-
-
Birmingham, Vereinigtes Königreich, B9 5SS
- Birmingham Heartlands Hospital
-
Bristol, Vereinigtes Königreich, BS2 8ED
- Bristol Haematology and Oncology Centre
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Dundee, Vereinigtes Königreich, DD1 9SY
- Ninewells Hospital
-
Glasgow, Vereinigtes Königreich, G12 0YN
- Beatson West of Scotland Cancer Centre
-
Guildford, Vereinigtes Königreich, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
-
Lecester, Vereinigtes Königreich, LE1 5WW
- Leicester Royal Infirmary
-
Leeds, Vereinigtes Königreich, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
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London, Vereinigtes Königreich, SE1 9RT
- Guy's Hospital
-
London, Vereinigtes Königreich, SW3 6JJ
- Royal Marsden Hospital
-
Sutton, Vereinigtes Königreich, SM2 5PT
- Royal Marsden Hospital
-
-
-
-
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Innsbruck, Österreich, 6020
- Universitaetsklinikum Innsbruck
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Linz, Österreich, 4021
- Allgemeines Krankenhaus der Stadt Linz
-
Salzburg, Österreich, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
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Wien, Österreich, 1130
- Krankenhaus Hietzing
-
Wien, Österreich, 1090
- AKH Wien
-
Wien, Österreich, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
-
Wien, Österreich, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Erlotinib
Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
|
150 mg tablet
Andere Namen:
|
Placebo-Komparator: Placebo
Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
|
Placebo-Tablette
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disease Free Survival (DFS)
Zeitfenster: 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)
Zeitfenster: 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).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival (OS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Proteinkinase-Inhibitoren
- Erlotinib-Hydrochlorid
Andere Studien-ID-Nummern
- OSI-774-302
- 2005-001747-29 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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