研究单位：[1]EMD Serono Research & Development Institute,Inc.[2]Cedars-Sinai Medical Center Los Angeles,California,United States,90048[3]All India Institute of Medical Sciences Marietta,Georgia,United States,30060[4]Dana-Farber Cancer Institute Boston,Massachusetts,United States,02215[5]Barbara Ann Karmanos Cancer Institute Detroit,Michigan,United States,48201[6]Montefiore Medical Center Radiology Bronx,New York,United States,10461[7]Perlmutter Cancer Center at NYU Langone Hospital ae Long Island New York,New York,United States,10016[8]University of Cincinnati Cancer Institute Cincinnati,Ohio,United States,45267[9]University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology Pittsburgh,Pennsylvania,United States,15219[10]Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization Greenville,South Carolina,United States,29605-4653[11]Instituto de Oncologia Angel Roffo Buenos Aires,Argentina[12]Centro Oncologico Riojano Integral (CORI) La Rioja,Argentina[13]CEMAIC - Centro Medico Privado Las Margaritas,Argentina[14]Fundacion Scherbovsky Mendoza,Argentina[15]Clinica Viedma S.A. Viedma,Argentina[16]LKH - Universitätsklinikum Graz - HNO-Universitätsklinik Graz,Austria[17]KABEG-Klinikum Klagenfurt - Department of Internal Medicine Klagenfurt am Wörthersee,Austria[18]Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO Linz,Austria[19]LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie Salzburg,Austria[20]Institut Jules Bordet - Medical Oncology Brussels,Belgium[21]Cliniques Universitaires Saint-Luc - STL Bruxelles,Belgium[22]Uza - Parent Wilrijk,Belgium[23]Grupo Oncoclínicas Barretos,Brazil[24]Hospital de Câncer de Barretos - Fundação Pio XII Barretos,Brazil[25]Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba,Brazil[26]CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica Florianopolis,Brazil[27]CRIO - Centro Regional Integrado de Oncologia Fortaleza,Brazil[28]Oncosite - Centro de Pesquisa Clinica e Oncologia Ijuí,Brazil[29]Instituto de Cancer de Londrina Londrina,Brazil[30]HGB - Hospital Giovanni Battista - Mãe de Deus Center Porto Alegre,Brazil[31]Hospital de Clínicas de Porto Alegre Porto Alegre,Brazil[32]Hospital Nossa Senhora da Conceicao Porto Alegre,Brazil[33]Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre,Brazil[34]Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia Salvador,Brazil[35]CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC Santo André,Brazil[36]INCA - Instituto Nacional de Câncer Sao Goncalo,Brazil[37]ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira Sao Paulo,Brazil[38]Hospital Beneficência Portuguesa de São Paulo São Paulo,Brazil[39]CHUM Centre de Recherche Montreal,Canada[40]CIUSSS du Centre Ouest de l'lle de Montreal - Not Applicable Montreal,Canada[41]Beijing Cancer Hospital Beijing,China[42]The First Affiliated Hospital of Bengbu Medical College Bengbu,China[43]The First Hospital of Jilin University Changchun,China[44]Hunan Cancer Hospital Changsha,China[45]Xiangya Hospital,Central South University Changsha,China[46]Sichuan Cancer Hospital Chengdu,China[47]West China Hospital,Sichuan University Chengdu,China[48]Chongqing University Cancer Hospital Chongqing,China[49]Fujian Cancer Hospital Fuzhou,China[50]Sun Yat-sen University,Cancer Center Guangzhou,China[51]Sir Run Run Shaw Hospital,Zhejiang University,School of Medicine Hangzhou,China[52]Zhejiang Cancer Hospital Hangzhou,China[53]Anhui Provincial Cancer Hospital Hefei,China[54]Shandong Cancer Hospital Jinan,China[55]Jiangxi Cancer Hospital Nanchang,China[56]Nanjing Drum Tower Hospital Nanjing,China[57]Guangxi Medical University Affiliated Tumor Hospital Nanning,China[58]Fudan University Shanghai Cancer Center Shanghai,China[59]Shanghai General Hospital Shanghai,China[60]Shengjing Hospital of China Medical University Shenyang,China[61]Tianjin Medical University Cancer Institute & Hospital Tianjin,China[62]Union Hospital,Tongji Medical College of Huazhong University of Science & Technology Wuhan,China[63]The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital) Xi'an,China[64]Northern Jiangsu People's Hospital Yangzhou,China[65]Henan Cancer Hospital Zhengzhou,China[66]Fakultni nemocnice Olomouc - Dept of Onkologicka klinika Olomouc,Czechia[67]Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika Praha 10,Czechia[68]Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika Praha 8,Czechia[69]ICO - Site Paul Papin - service d'oncologie medicale Angers Cedex 2,France[70]CHU Bordeaux - Service d'Oncologie Médicale Bordeaux,France[71]CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale Brest Cedex,France[72]Centre Francois Baclesse - Service d'Oncologie Medicale Caen Cedex 05,France[73]Centre Georges François Leclerc - Oncologie Médicale Dijon,France[74]Hopital Prive Drome Ardeche - Service D Oncologie Guilherand Granges,France[75]Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale Le Mans,France[76]Centre Oscar Lambret - service de cancerologie gynecologique Lille cedex,France[77]Centre Hospitalier de Bretagne Sud Lorient,France[78]Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale Lyon,France[79]Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs Marseille cedex 05,France[80]Institut Régional du Cancer de Montpellier - Service de Professeur Senesse Montpellier,France[81]Centre Azureen Cancerologie - Service De Radiotherapie Mougins,France[82]Centre Antoine Lacassagne - Service d'Hématologie Oncologie Nice cedex 02,France[83]Institut Curie - site de Paris - Service d'Oncologie Médicale Paris Cedex 05,France[84]Hopital Tenon - service radiologie et imagerie medicale Paris cedex,France[85]CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale Poitiers,France[86]Centre Henri Becquerel - Service de radiothérapie Rouen,France[87]Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie Saint Grégoire,France[88]ICO - Site René Gauducheau - Service d'Oncologie medicale SAINT-HERBLAIN Cedex,France[89]Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale Strasbourg Cedex,France[90]CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie Toulon cedex,France[91]Institut Claudius Regaud - service de Radiothérapie Toulouse cedex 09,France[92]CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale Tours,France[93]Institut Gustave Roussy - Oncologie Médicale Villejuif,France[94]High Technology Hospital Medcenter LLC Batumi,Georgia[95]Evex Hospitals Oncology Center Kutaisi,Georgia[96]Cancer Research Center Ltd. Tbilisi,Georgia[97]High Technology Medical Center,University Clinic Tbilisi,Georgia[98]New Hospitals Tbilisi,Georgia[99]Research Institute of Clinical Medicine Tbilisi,Georgia[100]Vivantes Klinikum Neukoelln - Parent Berlin,Germany[101]Universitaetsklinikum Jena - HNO_Klinik Jena,Germany[102]Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie Kiel,Germany[103]Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals-,Nasen- und Ohrenheilkunde Marburg,Germany[104]Universitaetsklinikum Regensburg - Innere Medizin III Haematologie,Onkologie Regensburg,Germany[105]Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie Rostock,Germany[106]Caritasklinik St. Theresia - Parent Saarbruecken,Germany[107]Tata Medical Centre Kolkata,India[108]Tata Memorial Hospital Mumbai,India[109]National Cancer Institu
The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.
