NBTXR3 med eller uten Cetuximab i LA-HNSCC
2. november 2026 oppdatert av: Johnson & Johnson Enterprise Innovation Inc.
En fase 3-studie av NBTXR3 aktivert av etterforskerens valg av strålebehandling alene eller strålebehandling i kombinasjon med Cetuximab for platinabasert kjemoterapi-ikke kvalifiserte eldre pasienter 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
500
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Brussels, Belgia, 1200
- Rekruttering
- Cliniques Universitaires Saint Luc
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Charleroi, Belgia, 6060
- Fullført
- Grand Hopital De Charleroi Site Les Viviers
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Leuven, Belgia, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Barretos, Brasil, 14784-400
- Rekruttering
- Fundacao Pio XII
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Belo Horizonte, Brasil, 30380 472
- Rekruttering
- Nucleo de Ensino e Pesquisa do Instituto Mario Penna
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Fortaleza, Brasil, 60336 232
- Fullført
- Centro Regional Integrado de Oncologia CRIO
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Fortaleza, Brasil, 60430-230
- Rekruttering
- Instituto Do Cancer Do Ceara
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Ipatinga, Brasil, 35160 158
- Rekruttering
- Fundacao Sao Francisco Xavier
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Jaú, Brasil, 17210 080
- Rekruttering
- Fundacao Doutor Amaral Carvalho
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Londrina, Brasil, 86015 520
- Rekruttering
- Hospital do Cancer de Londrina
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Porto Alegre, Brasil, 90610-000
- Rekruttering
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto Alegre, Brasil, 91350-200
- Fullført
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Brasil, 90050 170
- Rekruttering
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasil, 22 250 905
- Rekruttering
- Oncoclinicas Rio de Janeiro S A
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Salvador, Brasil, 41950 640
- Rekruttering
- Ensino e Terapia de Inovacao Clinica AMO Etica
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São José do Rio Preto, Brasil, 15090-000
- Rekruttering
- Funfarme Sjrp
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São Paulo, Brasil, 01246 000
- Rekruttering
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasil, 01308 050
- Rekruttering
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Vitória, Brasil, 29043 260
- Rekruttering
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Panagyurishte, Bulgaria, 4500
- Fullført
- MHAT Uni Hospital
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Sofia, Bulgaria, 1756
- Fullført
- 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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Las Piñas, Filippinene, 1742
- Fullført
- University of Perpetual Help Dalta Medical Center, Inc
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Manila, Filippinene, 1000
- Fullført
- Manila Doctors Hospital
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Pasig, Filippinene, 1600
- Aktiv, ikke rekrutterende
- The Medical City
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Quezon City, Filippinene, 1112
- Fullført
- St. Luke's Medical Center
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Tampere, Finland, 33520
- Fullført
- Tampereen Yliopistollinen Sairaala
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Rekruttering
- University of Alabama at Birmingham
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope
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La Jolla, California, Forente stater, 92093
- Rekruttering
- University of California at San Diego Moores Cancer Center
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Laguna Hills, California, Forente stater, 92653
- Fullført
- Memorial Radiation Oncology Medical Group Laguna Hills
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Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA Hematology Oncology
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Newport Beach, California, Forente stater, 92663
- Fullført
- Hoag Memorial Hospital
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San Francisco, California, Forente 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, Forente stater, 20052
- Rekruttering
- George Washington University Cancer Center
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic Jacksonville
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Orlando, Florida, Forente stater, 32803
- Rekruttering
- AdventHealth Orlando
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Rekruttering
- Emory University Hospital Midtown
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- Rekruttering
- University of Kentucky Markey Cancer Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston Medical Center
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New Mexico
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Santa Fe, New Mexico, Forente stater, 87505
- Fullført
- Christus St. Vincent Regional Cancer Center
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New York
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New York, New York, Forente stater, 10032
- Fullført
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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Staten Island, New York, Forente stater, 10310
- Rekruttering
- Richmond University Medical Center
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Montefiore Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- Rekruttering
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Atrium Health Levine Cancer Institute
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Rekruttering
- University of Cincinnati
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Rekruttering
- Stephenson Cancer Center
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania Perelman Center for Advanced Medicine
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- Rekruttering
- University of Virginia
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Norfolk, Virginia, Forente stater, 23507
- Rekruttering
- Macon Joan Brock Virginia Health Sciences Eastern Virginia Medical Group at Old Dominion University
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Amiens, Frankrike, 80000
- Rekruttering
- CHU Amiens Picardie
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Brest, Frankrike, 29609
- Rekruttering
- CHU Brest
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Caen, Frankrike, 14076
- Rekruttering
- Centre Francois Baclesse
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Dijon, Frankrike, 21000
- Rekruttering
- Centre Georges Francois Leclerc
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Lille, Frankrike, 59020
- Rekruttering
- Centre de Lutte contre le Cancer Centre Oscar Lambret
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Lyon, Frankrike, 69008
- Fullført
- Centre Leon Berard
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Marseille, Frankrike, 13385
- Rekruttering
- Hopital de la Timone
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Neuilly-sur-Seine, Frankrike, 92200
- Fullført
- Clinique Ambroise Pare
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Paris, Frankrike, 75248
- Rekruttering
- Institut Curie
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Paris, Frankrike, 75015
- Rekruttering
- Hopital Europeen Georges Pompidou
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Paris, Frankrike, 75970
- Rekruttering
- Hopital Tenon
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Pessac, Frankrike, 33604
- Rekruttering
- Hopital Haut Leveque
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Rennes, Frankrike, 35000
- Rekruttering
- Hopital Pontchaillou
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Rouen, Frankrike, 76038
- Rekruttering
- CLCC - Centre Henri Becquerel
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Saint-Etienne, Frankrike, 42055
- Rekruttering
- CHU Saint Etienne
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Valenciennes, Frankrike, 59322
- Fullført
- Centre Hospitalier de Valenciennes Hopital Jean Bernard
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Vandœuvre-lès-Nancy, Frankrike, 54500
- Rekruttering
- Institut de Cancerologie de Lorraine
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Villejuif, Frankrike, 94805
- Rekruttering
- Gustave Roussy
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Batumi, Georgia, 6000
- Rekruttering
- High Technology Hospital MedCenter Ltd Batumi
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Kutaisi, Georgia, 4600
- Rekruttering
- JSC Vian Kutaisi Referral Hospital
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Tbilisi, Georgia, 0112
- Fullført
- Todua Clinic
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Tbilisi, Georgia, 144
- Rekruttering
- Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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Athens, Hellas, 124 62
- Rekruttering
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Larissa, Hellas, 41110
- Rekruttering
- University Hospital Of Larissa
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Thessaloniki, Hellas, 57001
- Fullført
- Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Hellas, 54639
- Rekruttering
- Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
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Bangalore, India, 560054
- Rekruttering
- M S Ramaiah Memorial Hospital
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Chennai, India, 600035
- Fullført
- Apollo Speciality Hospital, Chennai
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Madurai, India, 625107
- Fullført
- Meenakshi Mission Hospital and Research Center
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Mumbai, India, 400012
- Rekruttering
- Tata Memorial Hospital
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Nashik, India, 422002
- Rekruttering
- HealthCare Global HCG Manavata Cancer Centre
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New Delhi, India, 110085
- Rekruttering
- Rajiv Gandhi Cancer Institute and Research Centre
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Pune, India, 411 001
- Fullført
- Grant Medical foundation Ruby Hall Clinic
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Vijayawada, India, 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
- Fullført
- Rambam Health Care Campus
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Jerusalem, Israel, 9112001
- Fullført
- Hadassah Medical Center
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Tel Aviv, Israel, 6423906
- Fullført
- 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
- Fullført
- 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
- Fullført
- The Affiliated Hospital of Bengbu Medical College
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Changsha, Kina, 410008
- Fullført
- 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
- Fullført
- 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
- Fullført
- 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
- Fullført
- 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
- Fullført
- Fudan University Shanghai Cancer Center
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Shenyang, Kina, 110042
- Fullført
- 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
- Fullført
- Second Affiliated Hospital, SooChow University
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Taiyuan, Kina, 30013
- Fullført
- Shanxi Provincial Cancer hospital
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Tianjin, Kina, 300060
- Fullført
- 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
- Fullført
- The first affiliated hospital of xiamen university
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Xuzhou, Kina, 221000
- Fullført
- The Affiliated Hospital of Xuzhou Medical University
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Zhengzhou, Kina, 450008
- Fullført
- Henan Cancer Hospital
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Zhuhai, Kina, 519000
- Rekruttering
- The Fifth Affiliated Hospital Sun Yat Sen University
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Zagreb, Kroatia, 10000
- Fullført
- Klinicki bolnicki centar Zagreb
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Braga, Portugal, 4710 243
- Fullført
- Uls Braga - Hosp. Braga
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Lisbon, Portugal, 1649 035
- Fullført
- 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
- Fullført
- 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, Romania, 22328
- Aktiv, ikke rekrutterende
- Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
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Belgrade, Serbia, 11000
- Fullført
- Institute of Oncology and Radiology of Serbia
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Belgrade, Serbia, 11000
- Fullført
- Vojnomedicinska Akademija
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Kamenitz, Serbia, 21204
- Fullført
- Institute of Oncology of Vojvodina
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Kragujevac, Serbia, 34000
- Fullført
- University Clinical Center Kragujevac
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Barakaldo, Spania, 48903
- Rekruttering
- Hosp. Univ. de Cruces
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Barcelona, Spania, 8035
- Rekruttering
- Hosp Univ Vall D Hebron
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Barcelona, Spania, 08036
- Fullført
- Hosp Clinic de Barcelona
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Jerez de la Frontera, Spania, 11407
- Rekruttering
- Hosp. de Jerez de La Frontera
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L'Hospitalet de Llobregat, Spania, 08908
- Rekruttering
- Instituto Catalan Deoncologia Hospital Duran I Reynals
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Las Palmas de Gran Canaria, Spania, 35001
- Fullført
- Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario
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Lugo, Spania, 27003
- Rekruttering
- Hosp. Univ. Lucus Augusti
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Madrid, Spania, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spania, 28007
- Rekruttering
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spania, 28040
- Rekruttering
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spania, 28050
- Fullført
- Hosp Univ Hm Sanchinarro
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Málaga, Spania, 29010
- Rekruttering
- Hosp Regional Univ de Malaga
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Pamplona, Spania, 31008
- Fullført
- Hosp. de Navarra
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Sabadell, Spania, 08208
- Rekruttering
- Hosp.Univ.Parc Tauli
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Santander, Spania, 39008
- Rekruttering
- Hosp. Univ. Marques de Valdecilla
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Seville, Spania, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Valencia, Spania, 46014
- Rekruttering
- Hosp. Gral. Univ. Valencia
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Valencia, Spania, 46009
- Rekruttering
- Inst. Valenciano de Oncologia
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Zaragoza, Spania, 50009
- Rekruttering
- Hosp. Clinico Univ. Lozano Blesa
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Edinburgh, Storbritannia, EH4 2XU
- Rekruttering
- Western General Hospital
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Glasgow, Storbritannia, G12 0YN
- Rekruttering
- NHS Greater Glasgow and Clyde
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Guildford, Storbritannia, GU2 7XX
- Rekruttering
- The Royal Surrey County Hospital NHS Foundation Trust
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London, Storbritannia, SW3 6JJ
- Rekruttering
- The Royal Marsden NHS Trust
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Newcastle upon Tyne, Storbritannia, NE7 7DN
- Rekruttering
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Nottingham, Storbritannia, NG5 1PB
- Rekruttering
- Nottingham City Hospital
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Gothenburg, Sverige, 41345
- Fullført
- Sahlgrenska Universitetssjukhuset
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Seoul, Sør -Korea, 06591
- Fullført
- The Catholic University of Korea Seoul St Mary s Hospital
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Suwon, Sør -Korea, 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, Tsjekkia, 779 00
- Fullført
- Fakultni nemocnice Olomouc
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Prague, Tsjekkia, 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
- Fullført
- Universitatsklinikum Jena
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München, Tyskland, 81675
- Fullført
- Klinikum rechts der Isar an der Technischen Universitat Munchen
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Rostock, Tyskland, 18059
- Fullført
- Universitaetsmedizin Rostock
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Budapest, Ungarn, 1062
- Fullført
- 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, Østerrike, 8036
- Fullført
- Medizinische Universitat Graz
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Innsbruck, Østerrike, 6020
- Rekruttering
- Medical University Innsbruck
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Linz, Østerrike, 4010
- Rekruttering
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Vienna, Østerrike, 1090
- Rekruttering
- Medizinische Universitaet Wien
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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One primary tumor lesion amendable for intratumoral injection
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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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
Solution for infusion
Andre navn:
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 navn:
Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Johnson & Johnson Enterprise Innovation Inc Clinical trial, Johnson & Johnson Enterprise Innovation Inc.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. desember 2021
Primær fullføring (Antatt)
30. juni 2028
Studiet fullført (Antatt)
30. juni 2028
Datoer for studieregistrering
Først innsendt
4. mai 2021
Først innsendt som oppfylte QC-kriteriene
13. mai 2021
Først lagt ut (Faktiske)
19. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Karsinom
- Neoplasmer, plateepitelceller
- Plateepitelkarsinom i hode og nakke
- Karsinom, plateepitel
- Aminosyrer, peptider og proteiner
- Proteiner
- Terapeutikk
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Cetuximab
- Strålebehandling
Andre studie-ID-numre
- NANORAY-312
- NANORAY-312 (Annen identifikator: Janssen Research & Development, LLC)
- 2024-520386-31-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .