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
2 other identifiers
interventional
1,252
18 countries
287
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Sep 2006
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedSeptember 17, 2015
September 1, 2015
6.6 years
September 7, 2006
April 2, 2014
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disease Free Survival (DFS)
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)
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).
Secondary Outcomes (7)
Overall Survival (OS)
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)
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
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
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
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)
- +2 more secondary outcomes
Study Arms (2)
Erlotinib
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- months from the day of surgery for patients who get chemotherapy
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (295)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
City of Hope Nat'l Medical Center
Duarte, California, 91010, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
USC/ Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, 94143-1770, United States
City of Hope Medical Group (COHMG)
South Pasadena, California, 91030, United States
Rocky Mountain Cancer Center- Aurora
Aurora, Colorado, 80012, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80303, United States
Penrose St. Francis Health Services
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80909, United States
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers- Rose
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120-4413, United States
Rocky Mountain Cancer Center-Sky Ridge
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Center-Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center
Sharon, Connecticut, 06069, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
Smilow Cancer Hospital Care Center
Torrington, Connecticut, 06790, United States
Florida Cancer Institute-New Hope
Hudson, Florida, 34667, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32204, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32216, United States
Watson Clinic LLP
Lakeland, Florida, 33805, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Florida Cancer Institute- New Hope
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, 30318, United States
Central Georgia Cancer Care, PC
Macon, Georgia, 31201, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Mountain States Tumor Institute
Meridian, Idaho, 83642, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Mountain States Tumor Institute
Twin Falls, Idaho, 83301, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago, Section of Hematology/Oncology
Chicago, Illinois, 60637, United States
Joliet Oncology Hematology Assoc., LTD
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University Health
Carmel, Indiana, 46032, United States
Indiana University Health
Fishers, Indiana, 46037, United States
Indiana University Health
Greenfield, Indiana, 46140, United States
Indiana University Health
Indianapolis, Indiana, 46219, United States
Indiana University Health
Indianapolis, Indiana, 46227, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
Norton Healthcare, Inc.
Louisville, Kentucky, 40202, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363, United States
Cancer Care of Maine
Brewer, Maine, 04412, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
St. Joseph Medical Center's Cancer Institute
Towson, Maryland, 21204, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435-2150, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology
Saint Paul, Minnesota, 55102-2389, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Heartland Regional Medical Center d/b/a Heartland Clinic
Saint Joseph, Missouri, 64507, United States
St. Francis Cancer Treatment Center
Grand Island, Nebraska, 68803, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
NH Oncology-Hematology PA (Co)
Concord, New Hampshire, 03301, United States
NH Oncology-Hematology PA
Hooksett, New Hampshire, 03106, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505, United States
Interlakes Oncology Hematology, PC
Brockport, New York, 14420, United States
Interlakes Oncology Hematology, PC
Canadaigua, New York, 14424, United States
Interlakes Oncology Hematology, PC
Geneva, New York, 14456, United States
Advanced Oncology Associates
New Rochelle, New York, 10801, United States
The New York Presbyterian-Weill Medical College of Cornell University
New York, New York, 10065, United States
Interlakes Oncology Hematology, PC
Rochester, New York, 14623, United States
Interlakes Oncology Hematology, PC
Rochester, New York, 14626, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
Cary, North Carolina, 27511, United States
Carolina Oncology Specialists PA
Hickory, North Carolina, 28602, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27609, United States
Aultman Hospital/ North Canton Medical Foundation
Canton, Ohio, 44710, United States
University Hopsitals of Cleveland
Cleveland, Ohio, 44106, United States
Hematology Oncology Consultants Inc.
Columbus, Ohio, 43228, United States
Earle A Chiles Research Institute
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97225, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062, United States
Cancer Care Associates - Medical Oncology
Bethlehem, Pennsylvania, 18015, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
South Carolina Oncology Assoc., PA
Columbia, South Carolina, 29210, United States
Cancer Centers of the Carolinas
Easley, South Carolina, 29640, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Cancer Centers of the Carolinas, Seneca
Seneca, South Carolina, 29672, United States
Cancer Centers of the Carolinas
Spartanburg, South Carolina, 29307, United States
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501, United States
Bostin Baskin Cancer Foundation
Germantown, Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Bostin Baskin Cancer Foundation
Memphis, Tennessee, 38104, United States
Family Cancer Center Foundation, Inc.
Memphis, Tennessee, 38119, United States
West Clinic
Memphis, Tennessee, 38120, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology, P.A. - Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology Beaumont
Beaumont, Texas, 77702-1449, United States
Texas Oncology Texas Cancer Center at Medical City
Dallas, Texas, 75230-2510, United States
Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028, United States
Texas Oncology, Fort Worth
Fort Worth, Texas, 76104, United States
Texas Oncology Southwest Forth Worth
Fort Worth, Texas, 76132, United States
Texas Oncology, Garland
Garland, Texas, 75042-5788, United States
Cancer Care Centers of South Texas - HOAST
New Braunfels, Texas, 78131, United States
Texas Oncology - Paris
Paris, Texas, 75460-5004, United States
Texas Oncology - Plano East
Plano, Texas, 75075-7787, United States
Cancer Care Centers of South Texas-HOAST
San Antonio, Texas, 78229, United States
Texas Oncology -Tyler
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712, United States
Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
Christiansburg, Virginia, 24073, United States
Onc and Hem Associates of SW VA, Inc.
Christiansburg, Virginia, 24073, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Univ. of Washington/ Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Cancer Care Northwest-North
Spokane, Washington, 99218, United States
Cancer Care Northwest-Valley
Spokane Valley, Washington, 99216, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Northwest Cancer Specialist, P.C.
Vancouver, Washington, 98686, United States
COIR
Mendoza, Mendoza Province, M5500AYB, Argentina
ISIS Centro Especializado De Luce S.A.
Santa Fé, Santa Fe Province, S3000FFU, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Hospital de Rehabilitación Respiratoria María Ferrer
Buenos Aires, C1272AAA, Argentina
Hospital Espanol de Rosario
Rosario, Santa Fe, S2001SBL, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Respiratory Clinical Trials Pty., Ltd
Adelaide, 5067, Australia
Ashford Cancer Centre
Ashford, SA 5037, Australia
Universitaetsklinikum Innsbruck
Innsbruck, 6020, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, 4021, Austria
Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
Salzburg, 5020, Austria
AKH Wien
Vienna, 1090, Austria
Krankenhaus Hietzing
Vienna, 1130, Austria
SMZ Baumgartner Hoehe - Otto Wagner Spital
Vienna, 1140, Austria
SMZ Baumgartner Höhe - Otto- Wagner-Spital
Vienna, A-1140, Austria
Hôpital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Le Grand Hôpital de Charleroi
Charleroi, 6000, Belgium
Centre Hospitalier Jolimont-Lobbes
La Louvière, 7100, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Center of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Stronach Regional cancer Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
RS MacLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, P6A 5K7, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
McGill Dept. of Oncology
Montreal, Quebec, H2W 1S6, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
St. Joseph's Health Centre
Toronto, M6R 1B5, Canada
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 370 87, Czechia
Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
Ostrava-Poruba, 70852, Czechia
FN Bulovka Klinika plincni a hrrudni chirurgie
Prague, 8 18081, Czechia
CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
Toulouse, Cedex 9, 31059, France
Centre d'Oncologie et de Radiothérapie du Pays Basque
Bayonne, 64100, France
C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
Brest, 29609, France
CHU de Caen - Service de pneumologie
Caen, 14033, France
CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
Clermont-Ferrand, 63003, France
Hopital De La Croix-Rousse Service de Pneumologie
Lyon, 69317, France
Institut Paoli-Calmettes
Marseille, 13273, France
Hôpital de Tenon
Paris, 75012, France
Fondation Hôpital Saint Joseph
Paris, 75014, France
Centre Catalan d'Oncologie
Perpignan, 66000, France
CHU - Hopital Pontchaillou - Service de pneumologie
Rennes, 35033, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271, France
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Zentralklinik Bad Berka
Bad Berka, 99437, Germany
HELIOS Klinikum Emil von Behring GmbH
Berlin, 14165, Germany
Augusta-Krankenanstalt Bochum
Bochum, 44791, Germany
Fachkrankenhaus Coswig
Coswig, 01640, Germany
Universitaetsklinikum Essen
Essen, 45122, Germany
Krankenhaus Nordwest
Frankfurt am Main, 60488, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Göttingen
Göttingen, 37075, Germany
Lungenclinic Großhansdorf
Großhansdorf, 22927, Germany
Städtisches Krankenhaus Martha-Maria, Halle-Dölau
Halle, 06120, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Thoraxklinik Heidelberg
Heidelberg, 69126, Germany
Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, 58675, Germany
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, 76137, Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitätsklinikum Mainz
Mainz, 55131, Germany
Asklepios Klinikum Gauting
Muenchen-Gauting, 82131, Germany
Pius Hospital Oldenburg
Oldenburg, 26121, Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78050, Germany
IASO GENERAL Hospital of Athens
Athens, 15562, Greece
"Papageorgiou" General Hospital of Thessaloniki
Thessaloniki, 54603, Greece
"G. Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, 57010, Greece
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1121, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika
Budapest, 1125, Hungary
Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
Deszk, 6772, Hungary
Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
Pécs, 7623, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, 8000, Hungary
Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
Szombathely, 9700, Hungary
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona, 60020, Italy
Ospedale Bellaria
Bologna, 40139, Italy
Ospedale Garibaldi Nesima
Catania, 95100, Italy
Istituto Nazionale per la Ricerca e la Cura del Cancro
Genova, 16132, Italy
Azienda Ospedaliero- Universitaria di Parma
Parma, 43100, Italy
Ospedale S. Maria della Misericordia
Perugia, 06132, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Samodzielny Publiczny Szpital Kliniczny Nr 4
Lublin, 20-954, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, 60-569, Poland
Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
Szczecin, 70-891, Poland
Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
Wroclaw, 53-439, Poland
Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
Oradea, Bihor County, 410032, Romania
Oncoloab SRL
Craiova, Dolj, 200535, Romania
Centrul de Oncologie Medicala
Iași, Iaşi, 700106, Romania
Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
Bucharest, 022328, Romania
Institutul Oncologic Al. Trestioreanu
Bucharest, 022328, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, 400015, Romania
Spitalul Clinic Judetean Sibiu
Sibiu, 550245, Romania
State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, 163045, Russia
State Healthcare Institution "Regional Clinical Oncology Dispensary"
Kemerovo, 650036, Russia
State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
Krasnodar, 350086, Russia
State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
Moscow, 105229, Russia
Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
Moscow, 115478, Russia
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, 197022, Russia
Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
Saint Petersburg, 197758, Russia
Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
Saint Petersburg, 198255, Russia
Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
Tomsk, 634050, Russia
State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, 150040, Russia
Saint Vincent's Hospital
Gyeonggi-do, 442-723, South Korea
Gachon Medical School Ghil Medical Center
Incheon, 405-760, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei Univ. College of Medicine
Seoul, 120-752, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
ICO (Institut Catalá d´Oncología)
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Fundació Althaia
Manresa, Barcelona, 08243, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Oncologico MD Anderson
Madrid, 28033, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Carlos Haya
Málaga, 29010, Spain
Hospital Clínico Virgen de la Victoria
Málaga, 29010, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario de Valme
Seville, 41700, Spain
Hospital Virgen de la Salud de Toledo
Toledo, 45004, Spain
Changhua Christian Hospital
Changhua, 500-06, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 833, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
The Royal Surrey County Hospital NHS Trust
Guildford, GU2 7XX, United Kingdom
Leicester Royal Infirmary
Lecester, LE1 5WW, United Kingdom
St James' Institute of Oncology, Bexley Wing, St James' University Hospital
Leeds, LS9 7TF, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crino L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.
PMID: 26324372DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director, Medical Oncology
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
September 1, 2006
Primary Completion
April 1, 2013
Study Completion
June 1, 2014
Last Updated
September 17, 2015
Results First Posted
June 3, 2014
Record last verified: 2015-09