NBTXR3 med eller uden cetuximab i LA-HNSCC
2. november 2026 opdateret af: Johnson & Johnson Enterprise Innovation Inc.
Et fase 3-studie af NBTXR3 aktiveret af investigators valg af strålebehandling alene eller strålebehandling i kombination med Cetuximab til platinbaseret kemoterapi-ikke-kvalificerede ældre patienter med LA-HNSCC
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
500
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Brussels, Belgien, 1200
- Rekruttering
- Cliniques Universitaires Saint Luc
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Charleroi, Belgien, 6060
- Afsluttet
- Grand Hopital De Charleroi Site Les Viviers
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Barretos, Brasilien, 14784-400
- Rekruttering
- Fundacao Pio XII
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Belo Horizonte, Brasilien, 30380 472
- Rekruttering
- Nucleo de Ensino e Pesquisa do Instituto Mario Penna
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Fortaleza, Brasilien, 60336 232
- Afsluttet
- Centro Regional Integrado de Oncologia CRIO
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Fortaleza, Brasilien, 60430-230
- Rekruttering
- Instituto Do Cancer Do Ceara
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Ipatinga, Brasilien, 35160 158
- Rekruttering
- Fundacao Sao Francisco Xavier
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Jaú, Brasilien, 17210 080
- Rekruttering
- Fundacao Doutor Amaral Carvalho
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Londrina, Brasilien, 86015 520
- Rekruttering
- Hospital do Cancer de Londrina
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Porto Alegre, Brasilien, 90610-000
- Rekruttering
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto Alegre, Brasilien, 91350-200
- Afsluttet
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Brasilien, 90050 170
- Rekruttering
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasilien, 22 250 905
- Rekruttering
- Oncoclinicas Rio de Janeiro S A
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Salvador, Brasilien, 41950 640
- Rekruttering
- Ensino e Terapia de Inovacao Clinica AMO Etica
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São José do Rio Preto, Brasilien, 15090-000
- Rekruttering
- Funfarme Sjrp
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São Paulo, Brasilien, 01246 000
- Rekruttering
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasilien, 01308 050
- Rekruttering
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Vitória, Brasilien, 29043 260
- Rekruttering
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Panagyurishte, Bulgarien, 4500
- Afsluttet
- MHAT Uni Hospital
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Sofia, Bulgarien, 1756
- Afsluttet
- Specialized Hospital for Active Treatment in Oncology
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Sunnybrook Health Sciences Center
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Rekruttering
- Western General Hospital
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Glasgow, Det Forenede Kongerige, G12 0YN
- Rekruttering
- NHS Greater Glasgow and Clyde
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Guildford, Det Forenede Kongerige, GU2 7XX
- Rekruttering
- The Royal Surrey County Hospital NHS Foundation Trust
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London, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- The Royal Marsden NHS Trust
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Rekruttering
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Nottingham, Det Forenede Kongerige, NG5 1PB
- Rekruttering
- Nottingham City Hospital
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Las Piñas, Filippinerne, 1742
- Afsluttet
- University of Perpetual Help Dalta Medical Center, Inc
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Manila, Filippinerne, 1000
- Afsluttet
- Manila Doctors Hospital
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Pasig, Filippinerne, 1600
- Aktiv, ikke rekrutterende
- The Medical City
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Quezon City, Filippinerne, 1112
- Afsluttet
- St. Luke's Medical Center
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Tampere, Finland, 33520
- Afsluttet
- Tampereen Yliopistollinen Sairaala
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- Rekruttering
- University of Alabama at Birmingham
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California
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope
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La Jolla, California, Forenede Stater, 92093
- Rekruttering
- University of California at San Diego Moores Cancer Center
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Laguna Hills, California, Forenede Stater, 92653
- Afsluttet
- Memorial Radiation Oncology Medical Group Laguna Hills
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Hematology Oncology
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Newport Beach, California, Forenede Stater, 92663
- Afsluttet
- Hoag Memorial Hospital
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San Francisco, California, Forenede Stater, 94158
- Rekruttering
- University of California San Francisco
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20052
- Rekruttering
- George Washington University Cancer Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Jacksonville
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- AdventHealth Orlando
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Rekruttering
- Emory University Hospital Midtown
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Rekruttering
- University of Kentucky Markey Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Rekruttering
- Boston Medical Center
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New Mexico
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Santa Fe, New Mexico, Forenede Stater, 87505
- Afsluttet
- Christus St. Vincent Regional Cancer Center
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New York
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New York, New York, Forenede Stater, 10032
- Afsluttet
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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Staten Island, New York, Forenede Stater, 10310
- Rekruttering
- Richmond University Medical Center
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The Bronx, New York, Forenede Stater, 10467
- Rekruttering
- Montefiore Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Atrium Health Levine Cancer Institute
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- University of Cincinnati
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Rekruttering
- Stephenson Cancer Center
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania Perelman Center for Advanced Medicine
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- University of Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Rekruttering
- Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
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Amiens, Frankrig, 80000
- Rekruttering
- CHU Amiens Picardie
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Brest, Frankrig, 29609
- Rekruttering
- CHU Brest
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Caen, Frankrig, 14076
- Rekruttering
- Centre Francois Baclesse
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Dijon, Frankrig, 21000
- Rekruttering
- Centre Georges Francois Leclerc
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Lille, Frankrig, 59020
- Rekruttering
- Centre de Lutte contre le Cancer Centre Oscar Lambret
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Lyon, Frankrig, 69008
- Afsluttet
- Centre Leon Berard
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Marseille, Frankrig, 13385
- Rekruttering
- Hopital de la Timone
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Neuilly-sur-Seine, Frankrig, 92200
- Afsluttet
- Clinique Ambroise Pare
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Paris, Frankrig, 75248
- Rekruttering
- Institut Curie
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Paris, Frankrig, 75015
- Rekruttering
- Hopital Europeen Georges Pompidou
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Paris, Frankrig, 75970
- Rekruttering
- Hopital Tenon
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Pessac, Frankrig, 33604
- Rekruttering
- Hopital Haut Leveque
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Rennes, Frankrig, 35000
- Rekruttering
- Hopital Pontchaillou
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Rouen, Frankrig, 76038
- Rekruttering
- CLCC - Centre Henri Becquerel
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Saint-Etienne, Frankrig, 42055
- Rekruttering
- CHU Saint Etienne
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Valenciennes, Frankrig, 59322
- Afsluttet
- Centre Hospitalier de Valenciennes Hopital Jean Bernard
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Vandœuvre-lès-Nancy, Frankrig, 54500
- Rekruttering
- Institut de Cancerologie de Lorraine
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Villejuif, Frankrig, 94805
- Rekruttering
- Gustave Roussy
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Batumi, Georgien, 6000
- Rekruttering
- High Technology Hospital MedCenter Ltd Batumi
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Kutaisi, Georgien, 4600
- Rekruttering
- JSC Vian Kutaisi Referral Hospital
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Tbilisi, Georgien, 0112
- Afsluttet
- Todua Clinic
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Tbilisi, Georgien, 144
- Rekruttering
- Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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Athens, Grækenland, 124 62
- Rekruttering
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Larissa, Grækenland, 41110
- Rekruttering
- University Hospital Of Larissa
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Thessaloniki, Grækenland, 57001
- Afsluttet
- Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Grækenland, 54639
- Rekruttering
- Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
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Bangalore, Indien, 560054
- Rekruttering
- M S Ramaiah Memorial Hospital
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Chennai, Indien, 600035
- Afsluttet
- Apollo Speciality Hospital, Chennai
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Madurai, Indien, 625107
- Afsluttet
- Meenakshi Mission Hospital and Research Center
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Mumbai, Indien, 400012
- Rekruttering
- Tata Memorial Hospital
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Nashik, Indien, 422002
- Rekruttering
- HealthCare Global HCG Manavata Cancer Centre
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New Delhi, Indien, 110085
- Rekruttering
- Rajiv Gandhi Cancer Institute and Research Centre
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Pune, Indien, 411 001
- Afsluttet
- Grant Medical foundation Ruby Hall Clinic
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Vijayawada, Indien, 520002
- Rekruttering
- HCG cancer center
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Ashdod, Israel, 7747629
- Aktiv, ikke rekrutterende
- Samson Assuta Ashdod University Hospital
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Haifa, Israel, 3109601
- Afsluttet
- Rambam Health Care Campus
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Jerusalem, Israel, 9112001
- Afsluttet
- Hadassah Medical Center
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Tel Aviv, Israel, 6423906
- Afsluttet
- Tel Aviv Sourasky Medical Center
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Bunkyō City, Japan, 113-8519
- Rekruttering
- Tokyo Medical and Dental University Hospital
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Hiroshima, Japan, 734 8551
- Rekruttering
- Hiroshima University Hospital
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Kashiwa, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Nagoya, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center
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Osaka, Japan, 541 8567
- Rekruttering
- Osaka International Cancer Institute
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Osaka Sayama Shi, Japan, 589 8511
- Afsluttet
- Kindai University Hospital
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Sendai, Japan, 980 8574
- Rekruttering
- Tohoku University Hospital
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Shimotsuke, Japan, 329-0498
- Rekruttering
- Jichi Medical University Hospital
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Shinjuku, Japan, 160 0023
- Rekruttering
- Tokyo Medical University Hospital
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Sunto Gun, Japan, 411 8777
- Rekruttering
- Shizuoka Cancer Center
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Bengbu, Kina, 233004
- Afsluttet
- The Affiliated Hospital of Bengbu Medical College
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Changsha, Kina, 410008
- Afsluttet
- Xiangya Hospital Central South University
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Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer hospital
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Chengdu, Kina, 610041
- Rekruttering
- Sichuan Cancer Hospital
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Dongguan, Kina, 523109
- Rekruttering
- Dongguan People s Hospital
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Fuzhou, Kina, 350005
- Rekruttering
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, Kina, 350001
- Afsluttet
- Fujian Medical University Union Hospital
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Fuzhou, Kina, 350014
- Rekruttering
- Fujian Medical University Fujian Provincial Cancer Hospital
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Guangzhou, Kina, 510180
- Rekruttering
- Guangzhou First Municipal People's Hospital
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Guangzhou, Kina, 510080
- Rekruttering
- The First Affiliated Hospital of Guangdong Pharmaceutical University
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Guangzhou, Kina, 510095
- Rekruttering
- Guangzhou Medical University Affiliated Oncology Hospital
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Jinan, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
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Jinan, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital
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Linyi, Kina, 276002
- Rekruttering
- Linyi Cancer Hospital
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Liuzhou, Kina, 545006
- Rekruttering
- Liuzhou people's Hospital
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Nanchang, Kina, 330029
- Afsluttet
- Jiangxi Cancer Hospital
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Nanjing, Kina, 223800
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Nanjing, Kina, 210009
- Afsluttet
- Jiangsu Cancer Hospital
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Nanning, Kina, 530000
- Rekruttering
- Wuming Hospital of Guangxi Medical University
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Nanning, Kina, 530021
- Rekruttering
- The Cancer Hospital Affiliated to Guangxi Medical University
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Qingdao, Kina, 266003
- Rekruttering
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Kina, 200032
- Afsluttet
- Fudan University Shanghai Cancer Center
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Shenyang, Kina, 110042
- Afsluttet
- Liaoning Cancer Hospital and Institute
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Shenzhen, Kina, 518036
- Rekruttering
- Peking University Shenzhen Hospital
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Shijiazhuang, Kina, 50011
- Rekruttering
- The Fourth Hospital of Hebei Medical University
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Suzhou, Kina, 215004
- Afsluttet
- Second Affiliated Hospital, SooChow University
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Taiyuan, Kina, 30013
- Afsluttet
- Shanxi Provincial Cancer hospital
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Tianjin, Kina, 300060
- Afsluttet
- Tianjin Medical University Cancer Institute and Hospital
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Wuhan, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Wuhan, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital
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Wuhan, Kina, 430030
- Rekruttering
- Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
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Xiamen, Kina, 361003
- Afsluttet
- The first affiliated hospital of xiamen university
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Xuzhou, Kina, 221000
- Afsluttet
- The Affiliated Hospital of Xuzhou Medical University
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Zhengzhou, Kina, 450008
- Afsluttet
- Henan Cancer Hospital
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Zhuhai, Kina, 519000
- Rekruttering
- The Fifth Affiliated Hospital Sun Yat Sen University
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Zagreb, Kroatien, 10000
- Afsluttet
- Klinicki bolnicki centar Zagreb
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Braga, Portugal, 4710 243
- Afsluttet
- Uls Braga - Hosp. Braga
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Lisbon, Portugal, 1649 035
- Afsluttet
- Uls Santa Maria - Hosp. Santa Maria
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Lisbon, Portugal, 1998050
- Rekruttering
- Hosp. Cuf Descobertas
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Porto, Portugal, 4099-001
- Afsluttet
- Uls Santo Antonio - Hosp. Santo Antonio
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Vila Nova de Gaia, Portugal, 4434 502
- Rekruttering
- Uls Gaia Espinho
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Bucharest, Rumænien, 22328
- Aktiv, ikke rekrutterende
- Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
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Belgrade, Serbien, 11000
- Afsluttet
- Institute of Oncology and Radiology of Serbia
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Belgrade, Serbien, 11000
- Afsluttet
- Vojnomedicinska Akademija
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Kamenitz, Serbien, 21204
- Afsluttet
- Institute of Oncology of Vojvodina
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Kragujevac, Serbien, 34000
- Afsluttet
- University Clinical Center Kragujevac
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Barakaldo, Spanien, 48903
- Rekruttering
- Hosp. Univ. de Cruces
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Barcelona, Spanien, 8035
- Rekruttering
- Hosp Univ Vall D Hebron
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Barcelona, Spanien, 08036
- Afsluttet
- Hosp Clinic de Barcelona
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Jerez de la Frontera, Spanien, 11407
- Rekruttering
- Hosp. de Jerez de La Frontera
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L'Hospitalet de Llobregat, Spanien, 08908
- Rekruttering
- Instituto Catalan Deoncologia Hospital Duran I Reynals
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Las Palmas de Gran Canaria, Spanien, 35001
- Afsluttet
- Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
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Lugo, Spanien, 27003
- Rekruttering
- Hosp. Univ. Lucus Augusti
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Madrid, Spanien, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28007
- Rekruttering
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spanien, 28040
- Rekruttering
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spanien, 28050
- Afsluttet
- Hosp Univ Hm Sanchinarro
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Málaga, Spanien, 29010
- Rekruttering
- Hosp Regional Univ de Malaga
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Pamplona, Spanien, 31008
- Afsluttet
- Hosp. de Navarra
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Sabadell, Spanien, 08208
- Rekruttering
- Hosp.Univ.Parc Tauli
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Santander, Spanien, 39008
- Rekruttering
- Hosp. Univ. Marques de Valdecilla
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Seville, Spanien, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Valencia, Spanien, 46014
- Rekruttering
- Hosp. Gral. Univ. Valencia
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Valencia, Spanien, 46009
- Rekruttering
- Inst. Valenciano de Oncologia
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Zaragoza, Spanien, 50009
- Rekruttering
- Hosp. Clinico Univ. Lozano Blesa
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Gothenburg, Sverige, 41345
- Afsluttet
- Sahlgrenska Universitetssjukhuset
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Seoul, Sydkorea, 06591
- Afsluttet
- The Catholic University of Korea Seoul St Mary s Hospital
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Suwon, Sydkorea, 16247
- Rekruttering
- The Catholic university of Korea, St. Vincent's Hospital
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Bei Qu, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
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Changhua, Taiwan, 500
- Rekruttering
- Changhua Christian Hospital
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Keelung, Taiwan, 20442
- Rekruttering
- Chang-Gung Memorial Hospital-Keelung
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Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Olomouc, Tjekkiet, 779 00
- Afsluttet
- Fakultni nemocnice Olomouc
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Prague, Tjekkiet, 180 81
- Aktiv, ikke rekrutterende
- Nemocnice Bulovka
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Giessen, Tyskland, 35392
- Rekruttering
- Universitaetsklinikum Giessen und Marburg GmbH
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Hanover, Tyskland, 30625
- Rekruttering
- Medizinische Hochschule Hannover
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Jena, Tyskland, 07747
- Afsluttet
- Universitatsklinikum Jena
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München, Tyskland, 81675
- Afsluttet
- Klinikum rechts der Isar an der Technischen Universitat Munchen
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Rostock, Tyskland, 18059
- Afsluttet
- Universitaetsmedizin Rostock
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Budapest, Ungarn, 1062
- Afsluttet
- Eszak Pesti Centrumkorhaz Honvedkorhaz
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Budapest, Ungarn, 1122
- Rekruttering
- Orszagos Onkologiai Intezet
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Szeged, Ungarn, 6720
- Rekruttering
- Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika
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Graz, Østrig, 8036
- Afsluttet
- Medizinische Universitat Graz
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Innsbruck, Østrig, 6020
- Rekruttering
- Medical University Innsbruck
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Linz, Østrig, 4010
- Rekruttering
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Vienna, Østrig, 1090
- Rekruttering
- Medizinische Universitaet Wien
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-
Age greater than or equal to (>=) 60 years old
-
Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
-
Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
-
One primary tumor lesion amendable for intratumoral injection
-
Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
- Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
- Grade >= 2 hearing loss or tinnitus,
- Grade >= 2 peripheral neuropathy,
- New York Heart Association Class 3
- Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14 or Aged >= 75 years old
-
Eastern cooperative oncology group (ECOG) performance status 0 to 1
-
Life expectancy >= 6 months
Exclusion Criteria:
- Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
- Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
- Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: JNJ-90301900 (NBTXR3)
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume. |
Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
Andre navne:
Solution for infusion
Andre navne:
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period. |
|
Aktiv komparator: Arm B: RT alone or RT in combination with cetuximab
Investigator's choice of RT alone or RT in combination with cetuximab. |
Solution for infusion
Andre navne:
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
Tidsramme: 30 months following first randomized participant
|
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first. |
30 months following first randomized participant
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 48 months following first randomized participant
|
Time from randomization to death from any cause. |
48 months following first randomized participant
|
|
Local-regional control
Tidsramme: 48 months following first randomized participant
|
Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first. |
48 months following first randomized participant
|
|
Distant control
Tidsramme: 48 months following first randomized participant
|
Time to distant progression: time from randomization to distant progression or death, whichever occurs first. |
48 months following first randomized participant
|
|
Quality of Life over time - QLQ H&N35
Tidsramme: 48 months following first randomized participant
|
Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H&N35). |
48 months following first randomized participant
|
|
Quality of Life over time - EQ 5D 5L
Tidsramme: 48 months following first randomized participant
|
Change from baseline over time in symptoms, function, and health related QOL using the 5 level EuroQol 5 dimension (EQ 5D 5L) instrument. |
48 months following first randomized participant
|
|
Safety across duration of study - AEs
Tidsramme: 48 months following first randomized participant
|
Adverse events (AEs). |
48 months following first randomized participant
|
|
Objective Response Rate (ORR)
Tidsramme: 48 months following first randomized participant
|
Rate of complete response (CR)+partial response (PR) [RESIST 1.1]. |
48 months following first randomized participant
|
|
Duration of Overall Response
Tidsramme: 48 months following first randomized participant
|
Time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first. |
48 months following first randomized participant
|
|
Head and Neck Cancer Specific Event-Free Survival
Tidsramme: 48 months following first randomized participant
|
Time from randomization to loco regional progression (including recurrence), distant progression, or head and neck cancer related death, as per RECIST 1.1, whichever occurs first. |
48 months following first randomized participant
|
|
Head and Neck Cancer-Specific Survival
Tidsramme: 48 months following first randomized participant
|
Time from randomization to head and neck cancer-related death. |
48 months following first randomized participant
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Johnson & Johnson Enterprise Innovation Inc Clinical trial, Johnson & Johnson Enterprise Innovation Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. december 2021
Primær færdiggørelse (Anslået)
30. juni 2028
Studieafslutning (Anslået)
30. juni 2028
Datoer for studieregistrering
Først indsendt
4. maj 2021
Først indsendt, der opfyldte QC-kriterier
13. maj 2021
Først opslået (Faktiske)
19. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Karcinom
- Neoplasmer, pladecelle
- Planocellulært karcinom i hoved og hals
- Karcinom, pladecelle
- Aminosyrer, peptider og proteiner
- Proteiner
- Terapeutik
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Cetuximab
- Strålebehandling
Andre undersøgelses-id-numre
- NANORAY-312
- NANORAY-312 (Anden identifikator: Janssen Research & Development, LLC)
- 2024-520386-31-00 (Registry Identifier: EUCT number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .