JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Last Updated May 14, 2025
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NANORAY-312
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 3 -
Sites
Sites -
Status
Recruiting
SUMMARY
Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility.
Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio:
* Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab
* Arm B: Investigator's choice of RT alone or RT in combination with cetuximab
All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period.
An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information
CONDITIONS
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Aged
ELIGIBILITY
Inclusion Criteria:
* Age greater than or equal to (>=) 60 years old
* 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 dis
DETAILS
LOCATIONS
Locations in:
United States, Austria, Belgium, Brazil, Bulgaria, China, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Japan, South Korea, Philippines, Portugal, Romania, Spain, Taiwan, United Kingdom, Croatia, Finland, Serbia
| Country (25) | City or Province (159) | Status |
| United States | Laguna Hills Memorial Radiation Oncology Medical Group Laguna Hills |
RECRUITING
|
| United States | Newport Beach Hoag Memorial Hospital |
RECRUITING
|
| United States | San Francisco University of California San Francisco |
RECRUITING
|
| United States | Tampa Moffitt Cancer Center |
RECRUITING
|
| United States | Santa Fe Christus St. Vincent Regional Cancer Center |
RECRUITING
|
| United States | Staten Island Richmond University Medical Center |
RECRUITING
|
| United States | Chapel Hill University of North Carolina at Chapel Hill |
RECRUITING
|
| United States | Oklahoma City Stephenson Cancer Center |
RECRUITING
|
| Austria | Graz Medizinische Universität Graz |
RECRUITING
|
| Austria | Linz Ordensklinikum Linz GmbH Barmherzige Schwestern |
RECRUITING
|
| Austria | Wien Medizinische Universitaet Wien |
RECRUITING
|
| Belgium | Brussels Cliniques Universitaires Saint Luc |
RECRUITING
|
| Belgium | Gilly Grand Hôpital de Charleroi - Site Saint-Joseph |
RECRUITING
|
| Belgium | Leuven Universitair Ziekenhuis Leuven |
RECRUITING
|
| Brazil | Barretos Fundacao Pio Xii - Hospital De Cancer De Barretos |
RECRUITING
|
| Brazil | Belo Horizonte Nucleo de Ensino e Pesquisa do Instituto Mario Penna |
RECRUITING
|
| Brazil | Fortaleza Centro Regional Integrado de Oncologia CRIO |
RECRUITING
|
| Brazil | Jau Hospital Amaral Carvalho |
RECRUITING
|
| Brazil | Porto Alegre Hospital Sao Lucas da PUCRS |
RECRUITING
|
| Brazil | Porto Alegre Hospital Nossa Senhora da Conceicao |
RECRUITING
|
| Brazil | Rio De Janeiro Grupo Oncoclinicas - Botafogo |
RECRUITING
|
| Brazil | Sao Paulo Hospital Sirio Libanes Sao Paulo |
RECRUITING
|
| Brazil | Sao Paulo Irmandade da Santa Casa de Misericordia de Porto Alegre |
RECRUITING
|
| Brazil | São José do Rio Preto Hospital de Base de Sao Jose do Rio Preto |
RECRUITING
|
| Bulgaria | Panagyurishte MHAT Uni Hospital |
RECRUITING
|
| China | Bengbu The Affiliated Hospital of Bengbu Medical College |
RECRUITING
|
| China | Changsha Xiangya Hospital Central South University |
COMPLETED
|
| China | ChangSha Hunan Cancer hospital |
RECRUITING
|
| China | Chengdu Sichuan Cancer Hospital |
RECRUITING
|
| China | Dongguan Dongguan People s Hospital |
RECRUITING
|
| China | Fu Zhou Shi Fujian Medical University Union Hospital |
RECRUITING
|
| China | Fuzhou The First Affiliated Hospital of Fujian Medical University |
RECRUITING
|
| China | Fuzhou Fujian Medical University Fujian Provincial Cancer Hospital |
RECRUITING
|
| China | Guangzhou The First Affiliated Hospital of Guangdong Pharmaceutical University |
RECRUITING
|
| China | Guangzhou Guangzhou Medical University Affiliated Oncology Hospital |
RECRUITING
|
| China | Guangzhou Guangzhou First Municipal People's Hospital |
RECRUITING
|
| China | Jinan Qilu Hospital of Shandong University |
RECRUITING
|
| China | Jinan Shandong Cancer Hospital |
RECRUITING
|
| China | Linyi Linyi Cancer Hospital |
RECRUITING
|
| China | Liuzhou Liuzhou people's Hospital |
RECRUITING
|
| China | Nanchang Jiangxi Cancer Hospital |
COMPLETED
|
| China | Nanjing Jiangsu Cancer Hospital |
RECRUITING
|
| China | Nanjing Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School |
RECRUITING
|
| China | Nanning Wuming Hospital of Guangxi Medical University |
RECRUITING
|
| China | Nanning The Cancer Hospital Affiliated to Guangxi Medical University |
RECRUITING
|
| China | Qingdao The Affiliated Hospital of Medical College Qingdao University |
RECRUITING
|
| China | Shanghai Fudan University Shanghai Cancer Center |
RECRUITING
|
| China | Shen Zhen Shi Peking University Shenzhen Hospital |
RECRUITING
|
| China | Shenyang Liaoning Cancer Hospital and Institute |
RECRUITING
|
| China | Shijiazhuang The Fourth Hospital of Hebei Medical University |
RECRUITING
|
| China | Suzhou Second Affiliated Hospital, SooChow University |
RECRUITING
|
| China | Taiyuan Shanxi Provincial Cancer hospital |
RECRUITING
|
| China | Tianjin Tianjin Medical University Cancer Institute and Hospital |
RECRUITING
|
| China | Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology |
RECRUITING
|
| China | Wuhan Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology |
RECRUITING
|
| China | Wuhan Hubei Cancer Hospital |
RECRUITING
|
| China | Xiamen The first affiliated hospital of xiamen university |
RECRUITING
|
| China | Xuzhou The Affiliated Hospital of Xuzhou Medical University |
RECRUITING
|
| China | Zhengzhou Henan Cancer Hospital |
COMPLETED
|
| China | Zhuhai The Fifth Affiliated Hospital Sun Yat Sen University |
RECRUITING
|
| Czechia | Olomouc Fakultni nemocnice Olomouc |
RECRUITING
|
| Czechia | Praha 8 Nemocnice Bulovka |
RECRUITING
|
| France | Amiens CHU Amiens Picardie |
RECRUITING
|
| France | Brest CHU Brest |
RECRUITING
|
| France | Caen Cedex 05 Centre Francois Baclesse |
RECRUITING
|
| France | Lille Cedex Centre de Lutte contre le Cancer Centre Oscar Lambret |
SUSPENDED
|
| France | Lyon Centre Leon Berard |
RECRUITING
|
| France | Marseille Hopital de la Timone |
RECRUITING
|
| France | Neuilly Sur Seine Clinique Ambroise Pare |
RECRUITING
|
| France | PARIS Cedex 5 Institut Curie |
RECRUITING
|
| France | Paris Hopital Europeen Georges Pompidou |
SUSPENDED
|
| France | Paris Hopital Tenon |
RECRUITING
|
| France | Pessac Hopital Haut Leveque |
RECRUITING
|
| France | Rennes Hopital Pontchaillou |
RECRUITING
|
| France | Rouen Cedex 1 CLCC - Centre Henri Becquerel |
RECRUITING
|
| France | Saint Etienne Cedex 2 CHU Saint Etienne |
RECRUITING
|
| France | Valenciennes cedex Centre Hospitalier de Valenciennes Hopital Jean Bernard |
RECRUITING
|
| France | Vandoeuvre les Nancy Institut de Cancerologie de Lorraine |
RECRUITING
|
| France | Villejuif Cedex Gustave Roussy |
RECRUITING
|
| Georgia | Batumi High Technology Hospital MedCenter Ltd Batumi |
RECRUITING
|
| Georgia | Kutaisi JSC Vian Kutaisi Referral Hospital |
RECRUITING
|
| Georgia | Tbilisi Todua Clinic |
SUSPENDED
|
| Georgia | Tbilisi Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic |
RECRUITING
|
| Germany | Giessen Universitaetsklinikum Giessen und Marburg GmbH |
RECRUITING
|
| Germany | Jena Universitatsklinikum Jena |
RECRUITING
|
| Germany | München Klinikum rechts der Isar an der Technischen Universitat Munchen |
RECRUITING
|
| Germany | Rostock Universitaetsmedizin Rostock |
RECRUITING
|
| Greece | Athens General Hospital of Athens Attikon |
RECRUITING
|
| Greece | Larissa University Hospital Of Larissa |
RECRUITING
|
| Greece | Thessaloniki Interbalkan Medical Center of Thessaloniki |
RECRUITING
|
| Hungary | Budapest Eszak Pesti Centrumkorhaz Honvedkorhaz |
RECRUITING
|
| Hungary | Budapest Orszagos Onkologiai Intezet |
RECRUITING
|
| Hungary | Szeged Szent Gyorgyi Albert Klinikai Kozpont Onkoterapias Klinika |
RECRUITING
|
| India | Bangalore M S Ramaiah Memorial Hospital |
RECRUITING
|
| India | Chennai Apollo Speciality Hospital, Chennai |
RECRUITING
|
| India | Madhurai Meenakshi Mission Hospital and Research Center |
COMPLETED
|
| India | Mumbai Tata Memorial Hospital |
RECRUITING
|
| India | Nashik HealthCare Global HCG Manavata Cancer Centre |
RECRUITING
|
| India | Pune Grant Medical foundation Ruby Hall Clinic |
RECRUITING
|
| Israel | Ashdod Samson Assuta Ashdod University Hospital |
RECRUITING
|
| Israel | Haifa Rambam Health Care Campus |
RECRUITING
|
| Israel | Jerusalem Hadassah Medical Center |
SUSPENDED
|
| Israel | Tel Aviv Tel Aviv Sourasky Medical Center |
RECRUITING
|
| Japan | Bunkyo Tokyo Medical and Dental University Hospital |
RECRUITING
|
| Japan | Hiroshima shi Hiroshima University Hospital |
RECRUITING
|
| Japan | Kashiwa National Cancer Center Hospital East |
RECRUITING
|
| Japan | Nagoya Aichi Cancer Center |
RECRUITING
|
| Japan | Osaka Sayama shi Kindai University Hospital |
RECRUITING
|
| Japan | Osaka Osaka International Cancer Institute |
RECRUITING
|
| Japan | Sendai-Shi Tohoku University Hospital |
RECRUITING
|
| Japan | Shimotsuke Jichi Medical University Hospital |
RECRUITING
|
| Japan | Shinjuku Tokyo Medical University Hospital |
RECRUITING
|
| Japan | Sunto Gun Shizuoka Cancer Center |
RECRUITING
|
| South Korea | Seoul Korea University Anam Hospital |
RECRUITING
|
| South Korea | Seoul Severance Hospital |
RECRUITING
|
| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
RECRUITING
|
| South Korea | Seoul Asan Medical Center (AMC) |
RECRUITING
|
| South Korea | Suwon si The Catholic university of Korea, St. Vincent's Hospital |
RECRUITING
|
| South Korea | Suwon si Ajou University Hospital |
COMPLETED
|
| Philippines | Las Pinas University of Perpetual Help Dalta Medical Center, Inc |
RECRUITING
|
| Philippines | Manila Manila Doctors Hospital |
RECRUITING
|
| Philippines | Pasig The Medical City |
RECRUITING
|
| Philippines | Quezon City St. Luke's Medical Center |
RECRUITING
|
| Portugal | Braga Uls Braga - Hosp. Braga |
COMPLETED
|
| Portugal | Lisboa Hosp. Cuf Descobertas |
RECRUITING
|
| Portugal | Vila Nova de Gaia Uls Gaia Espinho |
RECRUITING
|
| Romania | Bucuresti Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti |
RECRUITING
|
| Spain | Barakaldo Hosp. Univ. de Cruces |
RECRUITING
|
| Spain | Barcelona Hosp Clinic de Barcelona |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | L Hospitalet De Llobregat Instituto Catalan Deoncologia Hospital Duran I Reynals |
RECRUITING
|
| Spain | Lugo Hosp. Univ. Lucus Augusti |
RECRUITING
|
| Spain | Madrid Hosp Univ Fund Jimenez Diaz |
RECRUITING
|
| Spain | Madrid Hosp. Univ. 12 de Octubre |
RECRUITING
|
| Spain | Madrid Hosp Univ Hm Sanchinarro |
RECRUITING
|
| Spain | Málaga Hosp Regional Univ de Malaga |
RECRUITING
|
| Spain | Santander Hosp. Univ. Marques de Valdecilla |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
|
| Spain | Valencia Inst. Valenciano de Oncologia |
RECRUITING
|
| Taiwan | Bei Qu National Cheng Kung University Hospital |
RECRUITING
|
| Taiwan | Changhua Changhua Christian Hospital |
RECRUITING
|
| Taiwan | Keelung Chang-Gung Memorial Hospital-Keelung |
RECRUITING
|
| Taiwan | Taichung Taichung Veterans General Hospital |
RECRUITING
|
| Taiwan | Taipei National Taiwan University Hospital |
RECRUITING
|
| United Kingdom | Glasgow NHS Greater Glasgow and Clyde |
RECRUITING
|
| United Kingdom | Guildford The Royal Surrey County Hospital NHS Foundation Trust |
RECRUITING
|
| United Kingdom | Newcastle upon Tyne Newcastle upon Tyne Hospitals NHS Foundation Trust |
RECRUITING
|
| United States | New York Herbert Irving Comprehensive Cancer Center Columbia University Medical Center |
COMPLETED
|
| Spain | Valencia Hosp. Gral. Univ. Valencia |
RECRUITING
|
| United States | Los Angeles UCLA Hematology Oncology |
RECRUITING
|
| Bulgaria | Sofia Specialized Hospital for Active Treatment in Oncology |
COMPLETED
|
| Croatia | Zagreb Klinicki bolnicki centar Zagreb |
COMPLETED
|
| Finland | Tampere Tampereen Yliopistollinen Sairaala |
COMPLETED
|
| Serbia | Belgrade Institute of Oncology and Radiology of Serbia |
COMPLETED
|
| Serbia | Belgrade Vojnomedicinska Akademija |
COMPLETED
|
| Serbia | Kragujevac University Clinical Center Kragujevac |
COMPLETED
|
| Serbia | Sremska Kamenica Institute of Oncology of Vojvodina |
COMPLETED
|
| Spain | Las Palmas de Gran Canaria Hospitales Universitarios San Roque En Las Palmas de Gran Canaria Centro Oncologico Integral Canario |
TERMINATED
|
| Spain | Pamplona Hosp. de Navarra |
TERMINATED
|
Geo Locations
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