Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Head and Neck Cancer Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386550
• Other study ID #: MS202359_0002
• Secondary ID: 2022-001144-18
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2022
• Est. completion date: December 16, 2030

Study information

• Verified date: May 2024
• Source: EMD Serono
• Contact: US Medical Information
• Phone: 888-275-7376
• Email: eMediUSA[@]emdserono.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 16, 2030
• Est. primary completion date: October 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 and able to tolerate standard of care IMRT treatment according to Investigator assessment

• Participants with histologically confirmed squamous cell carcinoma with one of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx. Participants have received surgery with curative intent on these sites in the past 4 to 10 weeks before start of treatment (Cycle 1 Day 1)

• Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry (ICH)

• Participants with no residual disease by computed tomography (CT) or magnetic resonance imaging (MRI) and have a high risk of relapse with 1 or 2 of the following criteria, confirmed by local histopathology: • nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin less than or equal to (<=) 1 millimeter (mm)

• Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: estimated glomerular filtration rate (eGFR) < 60 milliliter per minute per 1.73 meter square (mL/min /1.73 m^2); History of hearing impairment, defined as Grade >= 2 audiometric hearing loss or tinnitus Grade >= 2. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy > = Grade 2 and if >= 70 years, unfit according to G8 questionnaire (Score <= 14) or ineligible for cisplatin treatment due to age limit according to national guidelines

• Participants with adequate renal, hematologic and hepatic function as defined in the protocol

• Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

• Any condition, including any uncontrolled disease state other than SCCHN that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation

• Participants with incomplete surgery

• Participants with recurrent or metastatic disease

• Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site

• Prior definitive, neoadjuvant, concurrent or adjuvant (C)RT to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents

• Participation in any interventional clinical study within 28 days prior to screening or during participation in this study

• Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast-enhanced CT scans

• Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation

• Other protocol-defined exclusion criteria could apply

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Xevinapant (Debio 1143)
Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Radiation:
• IMRT
Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.

Drug:
• Placebo
Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Locations

Country	Name	City	State
Argentina	Instituto de Oncologia Angel Roffo	Ciudad Autonoma Buenos Aires
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Argentina	CEMAIC- Centro Medico Privado	Las Margaritas
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	Clinica Viedma S.A.	Viedma
Austria	Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO	Linz
Austria	LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie	Salzburg
Belgium	Institut Jules Bordet - Medical Oncology	Anderlecht
Belgium	Cliniques Universitaires Saint-Luc - STL	Bruxelles
Belgium	Antwerp University Hospital (UZA Parent)	Edegem
Belgium	Vitaz	Sint-Niklaas
Brazil	Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor	Barretos
Brazil	Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer	Curitiba
Brazil	CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica	Florianópolis
Brazil	CRIO - Centro Regional Integrado de Oncologia	Fortaleza
Brazil	Oncosite - Centro de Pesquisa Clinica e Oncologia	Ijui
Brazil	Instituto de Cancer de Londrina	Londrina
Brazil	Liga Norte-Rio-Grandense Contra o Câncer	Natal
Brazil	HGB - Hospital Giovanni Battista - Mãe de Deus Center	Porto Alegre
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Grupo Oncoclínicas	Rio de Janeiro
Brazil	INCA - Instituto Nacional de Câncer	Rio de Janeiro
Brazil	Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia	Salvador
Brazil	CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC	Santo André
Brazil	BP A Beneficencia Portuguesa da Sao Paulo	São Paulo
Brazil	ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira	São Paulo
Brazil	ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira	São Paulo
Canada	Centre Hospitalier de l'Universite de Montreal.	Montreal
China	Beijing Cancer Hospital	Beijing
China	Hospital of Bengbu Medical College	Bengbu
China	The First Hospital of Jilin University	Changchun
China	Hunan Cancer Hospital	Changsha
China	Xiangya Hospital, Central South University	Changsha
China	Sichuan Cancer Hospital	Chengdu
China	West China Hospital, Sichuan University	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Sir Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Anhui Provincial Cancer Hospital	Hefei
China	Shandong Cancer Hospital	Jinan
China	Jiangxi Cancer Hospital	Nanchang
China	Nanjing Drum Tower Hospital	Nanjing
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning
China	Fudan University Shanghai Cancer Center	Shangai
China	Shanghai General Hospital	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan
China	The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)	Xi'an
China	Northern Jiangsu People's Hospital	Yangzhou
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni nemocnice Olomouc - Dept of Onkologicka klinika	Olomouc
Czechia	Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika	Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika	Praha 10
France	ICO - Site Paul Papin - service d'oncologie medicale	Angers Cedex 2
France	CHU Bordeaux - Service d'Oncologie Médicale	Bordeaux
France	CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale	Brest Cedex
France	Centre Francois Baclesse - Service d'Oncologie Medicale	Caen Cedex 05
France	Centre Georges François Leclerc - Oncologie Médicale	Dijon
France	Hopital Prive Drome Ardeche - Service D Oncologie	Guilherand Granges
France	Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale	Le Mans
France	Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale	Le Mans Cedex 02
France	Centre Oscar Lambret - service de cancerologie gynecologique	Lille cedex
France	Centre Hospitalier de Bretagne Sud	Lorient cedex
France	Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale	Lyon
France	Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs	Marseille Cedex 5
France	Institut Régional du Cancer de Montpellier - Service de Professeur Senesse	Montpellier
France	Centre Azureen Cancerologie - Service De Radiotherapie	Mougins
France	Centre Antoine Lacassagne - Service d'Hématologie Oncologie	Nice cedex 02
France	Hopital Tenon - service radiologie et imagerie medicale	Paris cedex
France	Institut Curie - site de Paris - Service d'Oncologie Médicale	Paris Cedex 05
France	CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale	Poitiers
France	Centre Henri Becquerel - Service de radiothérapie	Rouen
France	Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie	Saint Grégoire
France	ICO - Site René Gauducheau - Service d'Oncologie medicale	Saint Herblain
France	Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale	Strasbourg Cedex
France	CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie	Toulon cedex
France	Institut Claudius Regaud - service de Radiothérapie	Toulouse cedex 09
France	CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale	Tours
France	Institut Gustave Roussy - Oncologie Médicale	Villejuif cedex
Georgia	High Technology Hospital Medcenter LLC	Batumi
Georgia	JSC EVEX Hospitals	Kutaisi
Georgia	Cancer Research Center Ltd.	Tbilisi
Georgia	High Technology Medical Center, University Clinic	Tbilisi
Georgia	LLC Todua Clinic	Tbilisi
Georgia	New Hospitals	Tbilisi
Germany	Vivantes Klinikum Neukoelln - Parent	Berlin
Germany	Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik	Giessen
Germany	Universitaetsmedizin Goettingen - Georg-August-Universität	Goettingen
Germany	Universitaetsklinikum Jena - HNO_Klinik	Jena
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie	Kiel
Germany	Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie	Leipzig
Germany	Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie	Rostock
Greece	General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens	Athens
Greece	University General Hospital "Attikon"	Athens
Greece	Interbalkan Hospital of Thessaloniki	Thessaloniki
India	Tata Medical Centre	Kolkata
India	National Cancer Institute Nagpur	Nagpur
India	All India Institute of Medical Sciences	New Delhi
India	Regional Cancer Centre	Thiruvananthapuram
Israel	Soroka University Medical Center	Beer sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Chaim Sheba Medical Center - pt	Ramat Gan
Israel	Hadassah University Hospital - Ein Kerem	Yerushalayim
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica	Brescia
Italy	Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II	Cagliari
Italy	Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia	Candiolo
Italy	Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica	Firenze
Italy	IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare	Meldola
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo	Milano
Italy	IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica	Milano
Italy	Ospedale San Raffaele - U.O. di Oncologia Medica	Milano
Italy	A.O.U. Policlinico di Modena - U.O. Oncologia	Modena
Italy	Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia	Napoli
Italy	Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A	Napoli
Italy	IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2	Padova
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1	Roma
Italy	Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia	Rozzano
Japan	Hyogo Cancer Center - Dept of Head and Neck Surgery	Akashi-shi
Japan	National Cancer Center Hospital - Dept of Gastroenterology	Chuo-ku
Japan	NHO Kyushu Cancer Center - Dept of Head and Neck Surgery	Fukuoka-shi
Japan	Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery	Hidaka-shi
Japan	Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery	Hiroshima-shi
Japan	National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology	Kashiwa-shi
Japan	Kagawa University Hospital - Dept of Oncology	Kita-gun
Japan	Saitama Cancer Center - Dept of Head and Neck Surgery	Kitaadachi-gun
Japan	Kobe University Hospital - Dept of Oncology/Hematology	Kobe-shi
Japan	Cancer Institute Hospital of JFCR - Dept of Medical Oncology	Koto-ku
Japan	NHO Shikoku Cancer Center - Dept of Head and Neck Surgery	Matsuyama-shi
Japan	Aichi Cancer Center Hospital - Dept of Head and Neck Surgery	Nagoya-shi
Japan	Nagoya University Hospital - Dept of Otorhinolaryngology	Nagoya-shi
Japan	Okayama University Hospital - Dept of Otorhinolaryngology	Okayama-shi
Japan	Osaka International Cancer Institute - Dept of Head and Neck Surgery	Osaka-shi
Japan	Kindai University Hospital - Dept of Oncology	Osakasayama-shi
Japan	Hokkaido University Hospital - Dept of Otorhinolaryngology	Sapporo-shi
Japan	NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery	Sapporo-shi
Japan	Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery	Sendai-shi
Japan	Yokohama City University Hospital - Dept of Otorhinolaryngology	Yokohama-shi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si
Mexico	Hospital Civil Fray Antonio Alcalde - O.P.D. Hospital Civil de Guadalajara	Guadalajara
Mexico	Centro de Atención e Investigación Clínica en Oncología	Merida
Mexico	Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey
Netherlands	Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen - Cancer Center	Groningen
Netherlands	UMC Utrecht - Dept Medical Oncology	Utrecht
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy - Zaklad Medycyny Nuklearnej i Endokrynologii Onkolo	Gliwice
Portugal	Hospital de Braga - Serviço de Oncologia Medica	Braga
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto
Romania	Centrul medical Focus	Bucuresti
Romania	S.C Medisprof S.R.L - parent	Cluj-Napoca
Romania	S.C Radiotherapy Center Cluj S.R.L - Parent	ComunaFloresti
Romania	S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent	Craiova
Romania	S.C Oncocenter Oncologie Clinica S.R.L - parent	Timisoara
Spain	Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera	A Coruña
Spain	Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia	A Coruña
Spain	Hospital Clinic de Barcelona - Medical Oncology	Barcelona
Spain	Hospital del Mar - Servicio de Oncologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron - Oncology Dept.	Barcelona
Spain	ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica	Barcelona
Spain	ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia	Barcelona
Spain	Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia	Las Palmas de Gran Canaria
Spain	Hospital Universitario Lucus Augusti - Oncology	Lugo
Spain	Clinica Universidad de Navarra (MAD) - Oncology Service	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz - Oncology	Madrid
Spain	Hospital Universitario La Paz - Oncology Department	Madrid
Spain	Hospital Regional Universitario de Malaga - Oncology Dept	Málaga
Spain	Hospital Universitario Virgen del Rocio - Oncology Service	Sevilla
Switzerland	Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie	Basel
Switzerland	Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovanni	Bellinzona
Switzerland	CHUV, Lausanne University Hospital	Lausanne
Switzerland	Universitaetsspital Zuerich - Parent	Zuerich
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	ChangHua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chi Mei Hospital, Liouying	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital,Linkou	Taoyuan
United Kingdom	St James's University Hospital - Dept of Oncology	Leeds
United Kingdom	Royal Marsden Hospital-London - Dept of Haematology/Oncology Research	London
United Kingdom	The Christie Hospital - Dept of Oncology	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Musgrove Park Hospital - PARENT	Somerset
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton
United Kingdom	Torbay Hospital - PARENT	Torquay
United Kingdom	Clatterbridge Cancer Centre	Wirral
United States	University of Alabama at Birmingham - Dept of Radiation Oncology	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center Radiology	Bronx	New York
United States	University of Cincinnati Cancer Institute	Cincinnati	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Prisma Health Cancer Institute, ITOR, CRU	Greenville	South Carolina
United States	Perlmutter Cancer Center at NYU Langone Hospital ae Long Island	New York	New York
United States	University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Georgia,  Germany,  Greece,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival (DFS)		Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years
Secondary	Overall Survival (OS)		Time from randomization to death from any cause, assessed up to 5 years
Secondary	Time to Subsequent Cancer Treatments		Time from randomization to the start of first subsequent cancer treatment, assessed up to 5 years
Secondary	Number of Participants with Adverse Events (AEs) and Treatment-related AEs		Time from randomization until end of study (up to 5 years)
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score		Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
Secondary	Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score		Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
Secondary	Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)		Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)

External Links

•   Trial Awareness and Transparency website