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. září 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once.
Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses.
These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments.
Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up.
Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Typ studie
Intervenční
Zápis (Aktuální)
1252
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1272AAA
- Hospital de Rehabilitación Respiratoria María Ferrer
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Mendoza, Argentina, M5500AYB
- COIR
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Rosario, Santa Fe, Argentina, S2001SBL
- Hospital Espanol de Rosario
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Santa Fé, Argentina, S3000FFU
- ISIS Centro Especializado De Luce S.A.
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Adelaide, Austrálie, 5067
- Respiratory Clinical Trials Pty., Ltd
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Ashford, Austrálie, SA 5037
- Ashford Cancer Centre
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New South Wales
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Campbelltown, New South Wales, Austrálie, 2560
- Campbelltown Hospital
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Liverpool, New South Wales, Austrálie, 2170
- Liverpool Hospital
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St Leonards, New South Wales, Austrálie, 2065
- Royal North Shore Hospital
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Victoria
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East Bentleigh, Victoria, Austrálie, 3165
- Monash Medical Centre
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Fitzroy, Victoria, Austrálie, 3065
- St Vincent's Hospital Melbourne
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Heidelberg, Victoria, Austrálie, 3084
- Austin Hospital
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Brussels, Belgie, 1200
- Cliniques universitaires Saint-Luc
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Brussels, Belgie, 1070
- Hopital Erasme
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Charleroi, Belgie, 6000
- Le Grand Hôpital de Charleroi
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La Louvière, Belgie, 7100
- Centre Hospitalier Jolimont-Lobbes
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Bayonne, Francie, 64100
- Centre d'Oncologie et de Radiotherapie du pays Basque
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Brest cedex, Francie, 29609
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
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Caen Cedex, Francie, 14033
- CHU de Caen - Service de pneumologie
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Clermont-Ferrand cedex 1, Francie, 63003
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
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Lyon cedex 04, Francie, 69317
- Hopital De La Croix-Rousse Service de Pneumologie
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Marseille cedex 9, Francie, 13273
- Institut Paoli-Calmettes
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PARIS cedex 14, Francie, 75014
- Fondation Hopital Saint Joseph
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Paris, Francie, 75012
- Hôpital de Tenon
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Perpignan, Francie, 66000
- Centre Catalan d'Oncologie
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Rennes cedex 9, Francie, 35033
- CHU - Hopital Pontchaillou - Service de pneumologie
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Saint Priest en Jarez, Francie, 42271
- Institut de Cancérologie de la Loire
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Vandoeuvre-lès-Nancy Cedex, Francie, 54511
- Hôpital de Brabois
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Cedex 9
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Toulouse, Cedex 9, Francie, 31059
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
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Ancona, Itálie, 60020
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
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Bologna, Itálie, 40139
- Ospedale Bellaria
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Catania, Itálie, 95100
- Ospedale Garibaldi Nesima
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Genova, Itálie, 16132
- Istituto Nazionale per la Ricerca e la Cura del Cancro
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Parma, Itálie, 43100
- Azienda Ospedaliero- Universitaria di Parma
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Perugia, Itálie, 06132
- Ospedale S. Maria Della Misericordia
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Roma, Itálie, 00152
- Azienda Ospedaliera San Camillo Forlanini
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Toronto, Kanada, M6R 1B5
- St. Joseph's Health Centre
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Kingston, Ontario, Kanada, K7L 5P9
- Cancer Center of Southeastern Ontario at Kingston General Hospital
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Mississauga, Ontario, Kanada, L5M 2N1
- Trillium Health Partners - Credit Valley Hospital
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Newmarket, Ontario, Kanada, L3Y 2P9
- Stronach Regional cancer Centre at Southlake
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Oshawa, Ontario, Kanada, L1G 2B9
- RS MacLaughlin Durham Regional Cancer Centre
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Sault Ste Marie, Ontario, Kanada, P6A 5K7
- Sault Area Hospital
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Thunder Bay, Ontario, Kanada, P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto, Ontario, Kanada, M5G 2C4
- Toronto General Hospital
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Quebec
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Montreal, Quebec, Kanada, H3A 1A1
- Royal Victoria Hospital
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Montreal, Quebec, Kanada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Kanada, H2W 1S6
- McGill Dept. of Oncology
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Gyeonggi-Do, Korejská republika, 442-723
- Saint Vincent's Hospital
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Incheon, Korejská republika, 405-760
- Gachon Medical School Ghil Medical Center
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Seoul, Korejská republika, 138-736
- Asan Medical Center
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Seoul, Korejská republika, 110-744
- Seoul National University Hospital
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Seoul, Korejská republika, 120-752
- Severance Hospital, Yonsei Univ. College of Medicine
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Budapest, Maďarsko, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Budapest, Maďarsko, 1125
- Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
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Deszk, Maďarsko, 6772
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
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Pécs, Maďarsko, 7623
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
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Szekesfehervar, Maďarsko, 8000
- Fejer Megyei Szent Gyorgy Korhaz
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Szombathely, Maďarsko, 9700
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
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Bad Berka, Německo, 99437
- Zentralklinik Bad Berka
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Berlin, Německo, 14165
- Helios Klinikum Emil von Behring GmbH
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Bochum, Německo, 44791
- Augusta-Krankenanstalt Bochum
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Coswig, Německo, 01640
- Fachkrankenhaus Coswig
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Essen, Německo, 45122
- Universitaetsklinikum Essen
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Frankfurt/Main, Německo, 60488
- Krankenhaus Nordwest
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Freiburg, Německo, 79106
- Universitatsklinikum Freiburg
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Großhansdorf, Německo, 22927
- LungenClinic Grosshansdorf
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Göttingen, Německo, 37075
- Universitätsklinikum Göttingen
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Halle (Saale), Německo, 06120
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
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Hamburg, Německo, 21075
- Asklepios Klinik Harburg
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Heidelberg, Německo, 69126
- Thoraxklinik Heidelberg
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Hemer, Německo, 58675
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
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Karlsruhe, Německo, 76137
- St. Vincentius-Kliniken Karlsruhe
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Lübeck, Německo, 23538
- Universitaetsklinikum Schleswig-Holstein
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Mainz, Německo, 55131
- Universitätsklinikum Mainz
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Muenchen-Gauting, Německo, 82131
- Asklepios Klinikum Gauting
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Oldenburg, Německo, 26121
- Pius Hospital Oldenburg
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Villingen-Schwenningen, Německo, 78050
- Schwarzwald-Baar Klinikum
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Lublin, Polsko, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Otwock, Polsko, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Poznan, Polsko, 60-569
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
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Szczecin, Polsko, 70-891
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
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Warsaw, Polsko, 02-781
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
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Wroclaw, Polsko, 53-439
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
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Innsbruck, Rakousko, 6020
- Universitaetsklinikum Innsbruck
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Linz, Rakousko, 4021
- Allgemeines Krankenhaus der Stadt Linz
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Salzburg, Rakousko, 5020
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
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Wien, Rakousko, 1130
- Krankenhaus Hietzing
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Wien, Rakousko, 1090
- AKH Wien
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Wien, Rakousko, 1140
- SMZ Baumgartner Hoehe - Otto Wagner Spital
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Wien, Rakousko, A-1140
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
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Bucuresti, Rumunsko, 022328
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
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Bucuresti, Rumunsko, 022328
- Institutul Oncologic Al. Trestioreanu
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Cluj-Napoca, Rumunsko, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Iasi, Rumunsko, 700106
- Centrul de Oncologie Medicala
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Sibiu, Rumunsko, 550245
- Spitalul Clinic Judetean Sibiu
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Bihor
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Oradea, Bihor, Rumunsko, 410032
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
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Dolj
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Craiova, Dolj, Rumunsko, 200535
- Oncoloab SRL
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Arkhangelsk, Ruská Federace, 163045
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
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Kemerovo, Ruská Federace, 650036
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
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Krasnodar, Ruská Federace, 350086
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
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Moscow, Ruská Federace, 105229
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
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Moscow, Ruská Federace, 115478
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
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Saint-Petersburg, Ruská Federace, 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"
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Saint-Petersburg, Ruská Federace, 197758
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
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Saint-Petersburg, Ruská Federace, 198255
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
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Tomsk, Ruská Federace, 634050
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
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Yaroslavl, Ruská Federace, 150040
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
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Birmingham, Spojené království, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Spojené království, BS2 8ED
- Bristol Haematology and Oncology Centre
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Dundee, Spojené království, DD1 9SY
- Ninewells Hospital
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Glasgow, Spojené království, G12 0YN
- Beatson West of Scotland Cancer Centre
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Guildford, Spojené království, GU2 7XX
- The Royal Surrey County Hospital NHS Trust
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Lecester, Spojené království, LE1 5WW
- Leicester Royal Infirmary
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Leeds, Spojené království, LS9 7TF
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
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London, Spojené království, SE1 9RT
- Guy's Hospital
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London, Spojené království, SW3 6JJ
- Royal Marsden Hospital
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Sutton, Spojené království, SM2 5PT
- Royal Marsden Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Spojené státy, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- University of Arkansas for Medical Science
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California
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Beverly Hills, California, Spojené státy, 90211
- Tower Cancer Research Foundation
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Duarte, California, Spojené státy, 91010
- City of Hope Nat'l Medical Center
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Loma Linda, California, Spojené státy, 92354
- Loma Linda University Medical Center
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Los Angeles, California, Spojené státy, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Spojené státy, 90033
- USC/ Norris Comprehensive Cancer Center
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Newport Beach, California, Spojené státy, 92658
- Hoag Memorial Hospital Presbyterian
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Palm Springs, California, Spojené státy, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Pleasant Hill, California, Spojené státy, 94523
- Bay Area Cancer Research Group, LLC
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San Francisco, California, Spojené státy, 94143-1770
- University of California, San Francisco Comprehensive Cancer Center
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South Pasadena, California, Spojené státy, 91030
- City of Hope Medical Group (COHMG)
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University Of Colorado Hospital
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Aurora, Colorado, Spojené státy, 80012
- Rocky Mountain Cancer Center- Aurora
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Boulder, Colorado, Spojené státy, 80303
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Spojené státy, 80907
- Rocky Mountain Cancer Center
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Colorado Springs, Colorado, Spojené státy, 80907
- Penrose St. Francis Health Services
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Colorado Springs, Colorado, Spojené státy, 80909
- Rocky Mountain Cancer Center
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Denver, Colorado, Spojené státy, 80218
- Rocky Mountain Cancer Center-Midtown
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Denver, Colorado, Spojené státy, 80220
- Rocky Mountain Cancer Centers- Rose
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Lakewood, Colorado, Spojené státy, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, Spojené státy, 80120-4413
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Spojené státy, 80124
- Rocky Mountain Cancer Center-Sky Ridge
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Longmont, Colorado, Spojené státy, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Spojené státy, 80138
- Rocky Mountain Cancer Center-Parker
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Thornton, Colorado, Spojené státy, 80260
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Yale University
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Sharon, Connecticut, Spojené státy, 06069
- Smilow Cancer Hospital Care Center
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Stamford, Connecticut, Spojené státy, 06902
- Hematology Oncology, P.C.
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Torrington, Connecticut, Spojené státy, 06790
- Smilow Cancer Hospital Care Center
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Florida
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Hudson, Florida, Spojené státy, 34667
- Florida Cancer Institute-New Hope
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Jacksonville, Florida, Spojené státy, 32204
- Cancer Specialists of North Florida
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Jacksonville, Florida, Spojené státy, 32216
- Cancer Specialists of North Florida
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Lakeland, Florida, Spojené státy, 33805
- Watson Clinic LLP
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Miami, Florida, Spojené státy, 33176
- Advanced Medical Specialties
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New Port Richey, Florida, Spojené státy, 34655
- Florida Cancer Institute- New Hope
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Orlando, Florida, Spojené státy, 32806
- Florida Cancer Specialists
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Port St. Lucie, Florida, Spojené státy, 34952
- Hematology Oncology Associates of the Treasure Coast
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Georgia
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Atlanta, Georgia, Spojené státy, 30318
- Peachtree Hematology-Oncology Consultants, P.C.
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Macon, Georgia, Spojené státy, 31201
- Central Georgia Cancer Care, PC
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Marietta, Georgia, Spojené státy, 30060
- Northwest Georgia Oncology Centers, PC
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Idaho
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Boise, Idaho, Spojené státy, 83712
- Mountain States Tumor Institute
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Meridian, Idaho, Spojené státy, 83642
- Mountain States Tumor Institute
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Post Falls, Idaho, Spojené státy, 83854
- Kootenai Cancer Center
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Twin Falls, Idaho, Spojené státy, 83301
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Rush University Medical Center
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Chicago, Illinois, Spojené státy, 60637
- University of Chicago, Section of Hematology/Oncology
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Joliet, Illinois, Spojené státy, 60435
- Joliet Oncology Hematology Assoc., LTD
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Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center
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Indiana
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Carmel, Indiana, Spojené státy, 46032
- Indiana University Health
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Fishers, Indiana, Spojené státy, 46037
- Indiana University Health
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Greenfield, Indiana, Spojené státy, 46140
- Indiana University Health
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Indianapolis, Indiana, Spojené státy, 46219
- Indiana University Health
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Indianapolis, Indiana, Spojené státy, 46227
- Indiana University Health
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Kansas
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Westwood, Kansas, Spojené státy, 66205
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Spojené státy, 40202
- Norton Healthcare, Inc.
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Louisiana
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Houma, Louisiana, Spojené státy, 70363
- Leonard J. Chabert Medical Center
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Maine
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Brewer, Maine, Spojené státy, 04412
- Cancer Care of Maine
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Maryland
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Baltimore, Maryland, Spojené státy, 21204
- Greater Baltimore Medical Center
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Towson, Maryland, Spojené státy, 21204
- St. Joseph Medical Center's Cancer Institute
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02135
- Caritas St. Elizabeth's Medical Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106
- St. Joseph Mercy Hospital
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Minnesota
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Burnsville, Minnesota, Spojené státy, 55337
- Minnesota Oncology Hematology, P.A.
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Edina, Minnesota, Spojené státy, 55435-2150
- Minnesota Oncology Hematology, P.A.
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Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology Hematology, P.A.
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Minneapolis, Minnesota, Spojené státy, 55404
- Minnesota Oncology Hematology, P.A.
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St. Paul, Minnesota, Spojené státy, 55102-2389
- Minnesota Oncology Hematology
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Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology Hematology, P.A.
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Missouri
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Columbia, Missouri, Spojené státy, 65201
- Missouri Cancer Associates
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St. Joseph, Missouri, Spojené státy, 64507
- Heartland Regional Medical Center d/b/a Heartland Clinic
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Nebraska
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Grand Island, Nebraska, Spojené státy, 68803
- St. Francis Cancer Treatment Center
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Omaha, Nebraska, Spojené státy, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, Spojené státy, 89052
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Spojené státy, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89169
- Comprehensive Cancer Centers of Nevada
-
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New Hampshire
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Concord, New Hampshire, Spojené státy, 03301
- NH Oncology-Hematology PA (Co)
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Hooksett, New Hampshire, Spojené státy, 03106
- NH Oncology-Hematology PA
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Lebanon, New Hampshire, Spojené státy, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
-
Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
-
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New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87131
- University of New Mexico Health Science Center
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Santa Fe, New Mexico, Spojené státy, 87505
- CHRISTUS St. Vincent Regional Cancer Center
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New York
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Brockport, New York, Spojené státy, 14420
- Interlakes Oncology Hematology, PC
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Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center
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Canadaigua, New York, Spojené státy, 14424
- Interlakes Oncology Hematology, PC
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Geneva, New York, Spojené státy, 14456
- Interlakes Oncology Hematology, PC
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New Rochelle, New York, Spojené státy, 10801
- Advanced Oncology Associates
-
New York, New York, Spojené státy, 10065
- The New York Presbyterian-Weill Medical College of Cornell University
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Rochester, New York, Spojené státy, 14623
- Interlakes Oncology Hematology, PC
-
Rochester, New York, Spojené státy, 14626
- Interlakes Oncology Hematology, PC
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Stony Brook, New York, Spojené státy, 11794
- Stony Brook University Medical Center
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North Carolina
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Cary, North Carolina, Spojené státy, 27511
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
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Hickory, North Carolina, Spojené státy, 28602
- Carolina Oncology Specialists PA
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Raleigh, North Carolina, Spojené státy, 27607
- Raleigh Hematology Oncology Associates
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Raleigh, North Carolina, Spojené státy, 27609
- Raleigh Hematology Oncology Associates
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Ohio
-
Canton, Ohio, Spojené státy, 44710
- Aultman Hospital/ North Canton Medical Foundation
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Cleveland, Ohio, Spojené státy, 44106
- University Hopsitals of Cleveland
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Columbus, Ohio, Spojené státy, 43228
- Hematology Oncology Consultants Inc.
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Oregon
-
Portland, Oregon, Spojené státy, 97213
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Spojené státy, 97225
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Spojené státy, 97227
- Northwest Cancer Specialists, PC
-
Portland, Oregon, Spojené státy, 97213
- Earle A Chiles Research Institute
-
Tualatin, Oregon, Spojené státy, 97062
- Northwest Cancer Specialists, PC
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Spojené státy, 18015
- Cancer Care Associates - Medical Oncology
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- The Hospital of the University of Pennsylvania
-
Pittsburg, Pennsylvania, Spojené státy, 15212
- Allegheny General Hospital
-
-
South Carolina
-
Columbia, South Carolina, Spojené státy, 29210
- South Carolina Oncology Assoc., PA
-
Easley, South Carolina, Spojené státy, 29640
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Spojené státy, 29605
- Cancer Centers of the Carolinas
-
Greenville, South Carolina, Spojené státy, 29615
- Cancer Centers of the Carolinas
-
Seneca, South Carolina, Spojené státy, 29672
- Cancer Centers of the Carolinas, Seneca
-
Spartanburg, South Carolina, Spojené státy, 29307
- Cancer Centers of the Carolinas
-
-
Tennessee
-
Cookeville, Tennessee, Spojené státy, 38501
- Cookeville Regional Medical Center
-
Germantown, Tennessee, Spojené státy, 38138
- Bostin Baskin Cancer Foundation
-
Knoxville, Tennessee, Spojené státy, 37909
- Tennessee Cancer Specialists
-
Memphis, Tennessee, Spojené státy, 38120
- West Clinic
-
Memphis, Tennessee, Spojené státy, 38119
- Family Cancer Center Foundation, Inc.
-
Memphis, Tennessee, Spojené státy, 38104
- Bostin Baskin Cancer Foundation
-
Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Cancer Center
-
Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Amarillo, Texas, Spojené státy, 79106
- Texas Oncology, P.A. - Amarillo
-
Beaumont, Texas, Spojené státy, 77702-1449
- Texas Oncology Beaumont
-
Dallas, Texas, Spojené státy, 75246
- Baylor Charles A Sammons Cancer Center
-
Dallas, Texas, Spojené státy, 75230-2510
- Texas Oncology Texas Cancer Center at Medical City
-
Flower Mound, Texas, Spojené státy, 75028
- Texas Oncology - Flower Mound
-
Fort Worth, Texas, Spojené státy, 76132
- Texas Oncology Southwest Forth Worth
-
Ft. Worth, Texas, Spojené státy, 76104
- Texas Oncology, Fort Worth
-
Garland, Texas, Spojené státy, 75042-5788
- Texas Oncology, Garland
-
New Braunfels, Texas, Spojené státy, 78131
- Cancer Care Centers of South Texas - HOAST
-
Paris, Texas, Spojené státy, 75460-5004
- Texas Oncology - Paris
-
Plano, Texas, Spojené státy, 75075-7787
- Texas Oncology - Plano East
-
San Antonio, Texas, Spojené státy, 78229
- Cancer Care Centers of South Texas-HOAST
-
Tyler, Texas, Spojené státy, 75702
- Texas Oncology -Tyler
-
Waco, Texas, Spojené státy, 76712
- Texas Oncology Cancer Care and Research Center
-
-
Virginia
-
Christiansburg, Virginia, Spojené státy, 24073
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Christiansburg, Virginia, Spojené státy, 24073
- Onc and Hem Associates of SW VA, Inc.
-
Hampton, Virginia, Spojené státy, 23666
- Virginia Oncology Associates
-
Newport News, Virginia, Spojené státy, 23606
- Virginia Oncology Associates
-
Norfolk, Virginia, Spojené státy, 23502
- Virginia Oncology Associates
-
Roanoke, Virginia, Spojené státy, 24014
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
Salem, Virginia, Spojené státy, 24153
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
-
Wytheville, Virginia, Spojené státy, 24382
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
-
-
Washington
-
Seattle, Washington, Spojené státy, 98109
- Univ. of Washington/ Seattle Cancer Care Alliance
-
Spokane, Washington, Spojené státy, 99218
- Cancer Care Northwest-North
-
Spokane, Washington, Spojené státy, 99202
- Cancer Care Northwest
-
Spokane Valley, Washington, Spojené státy, 99216
- Cancer Care Northwest-Valley
-
Vancouver, Washington, Spojené státy, 98684
- Northwest Cancer Specialists, P.C.
-
Vancouver, Washington, Spojené státy, 98686
- Northwest Cancer Specialist, P.C.
-
-
-
-
-
Changhua, Tchaj-wan, 500-06
- Changhua Christian Hospital
-
Kaohsiung, Tchaj-wan, 833
- Chang Gung Medical Foundation
-
Taichung, Tchaj-wan, 404
- China Medical University Hospital
-
Taichung, Tchaj-wan, 402
- Chung Shan Medical University Hospital
-
Taichung, Tchaj-wan, 407
- Taichung Veterans General Hospital
-
Taipei, Tchaj-wan, 112
- Taipei Veterans General Hospital
-
Taoyuan, Tchaj-wan, 333
- Chang Gung Memorial Hospital
-
-
-
-
-
Ceske Budejovice, Česká republika, 370 87
- Nemocnice České Budějovice, a.s.
-
Ostrava-Poruba, Česká republika, 70852
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
-
Praha, Česká republika, 8 18081
- FN Bulovka Klinika plincni a hrrudni chirurgie
-
-
-
-
-
Athens, Řecko, 15562
- IASO General Hospital of Athens
-
Thessaloniki, Řecko, 54603
- "Papageorgiou" General Hospital of Thessaloniki
-
Thessaloniki, Řecko, 57010
- "G. Papanikolaou" General Hospital of Thessaloniki
-
-
-
-
-
Madrid, Španělsko, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Španělsko, 28046
- Hospital Universitario La Paz
-
Madrid, Španělsko, 28033
- Hospital Oncologico MD Anderson
-
Málaga, Španělsko, 29010
- Hospital Carlos Haya
-
Málaga, Španělsko, 29010
- Hospital Clínico Virgen de la Victoria
-
Pamplona, Španělsko, 31008
- Clinica Universitaria de Navarra
-
Santander, Španělsko, 39008
- Hospital Universitario Marqués de Valdecilla
-
Sevilla, Španělsko, 41700
- Hospital Universitario de Valme
-
Toledo, Španělsko, 45004
- Hospital Virgen de la Salud de Toledo
-
Valencia, Španělsko, 46014
- Hospital General Universitario de Valencia
-
-
Barcelona
-
L' Hospitalet de Llobregat, Barcelona, Španělsko, 08907
- ICO (Institut Catalá d´Oncología)
-
Manresa, Barcelona, Španělsko, 08243
- Fundació Althaia
-
Sabadell, Barcelona, Španělsko, 08208
- Corporacio Sanitaria Parc Tauli
-
-
Madrid
-
Majadahonda, Madrid, Španělsko, 28222
- Hospital Puerta de Hierro Majadahonda
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
Ostatní jména:
|
|
Komparátor placeba: 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 tableta
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Disease Free Survival (DFS)
Časové okno: 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)
Časové okno: 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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2006
Primární dokončení (Aktuální)
1. dubna 2013
Dokončení studie (Aktuální)
1. června 2014
Termíny zápisu do studia
První předloženo
7. září 2006
První předloženo, které splnilo kritéria kontroly kvality
7. září 2006
První zveřejněno (Odhad)
8. září 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
17. září 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. září 2015
Naposledy ověřeno
1. září 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Novotvary
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Inhibitory proteinkinázy
- Erlotinib hydrochlorid
Další identifikační čísla studie
- OSI-774-302
- 2005-001747-29 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .