Spots Global Cancer Trial Database for Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
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Trial Identification
Brief Title: Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Official Title: Radiotherapy Plus Xevinapant or Placebo in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma: a Randomized Phase II Study RAVINA
Study ID: NCT05724602
Study Description
Brief Summary: This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx. Upon confirmation of eligibility, subjects will be enrolled and randomized in a 1:1 ratio to: * Arm A: 3 cycles of xevinapant (200 mg/day from Day 1 to 14, per cycle) + intensive modulated radiotherapy (IMRT) followed by 3 cycles of xevinapant in monotherapy phase (200 mg/day from Day 1 to 14, per cycle) * Arm B: 3 cycles of placebo (from Day 1 to 14, per cycle) + IMRT followed by 3 cycles of placebo in monotherapy phase (from Day 1 to 14, per cycle). Patients will be stratified by institution, disease location/p16 status (p16 positive oropharyngeal cancer, versus others), G8 score. Three strata for the G8 will be used (\>14, versus 11-14 versus \<11). Patients will undergo imaging in week 20 and upon clinical suspicion of progression/recurrence. Clinical examination will take place every 12 weeks in the first 3 years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Onze Lieve Vrouw Ziekenhuis, Aalst, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, , Belgium
Centre Oscar Lambret, Lille, , France
Institut de Cancerologie de Lorraine, Nancy, , France
Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere, Paris, , France
Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital Tenon, Paris, , France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum, Berlin, , Germany
Universitaetsklinikum - Essen, Essen, , Germany
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center, Hamburg, , Germany
University Hospital Galway, Galway, , Ireland
St Luke Hospital & SLRON - SLRON - St. Luke'S Hospital Rathgar, Rathgar, , Ireland
IRCCS--Ospedale Bellaria-Bologna, Bologna, , Italy
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi, Florence, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Amsterdam UMC - locatie VUMC, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen - University Medical Center Groningen, Groningen, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Helse Bergen HF -Haukeland Hospital - Univ. Hosp, Bergen, , Norway
Oslo University Hospital - Radiumhospitalet, Oslo, , Norway
The Institute Of Oncology, Ljubljana, , Slovenia
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Vall D Hebron - Hospital Universitari Vall d'Hebron, Barcelona, , Spain
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Wirral, Birkenhead, , United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre, Bristol, , United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
Contact Details
Name: Sjoukje Oosting, Dr
Affiliation: University Medical Center Groningen
Role: STUDY_CHAIR
Name: Pierluigi Bonomo, Dr
Affiliation: Azienda Ospedaliero-Universitaria Careggi
Role: STUDY_CHAIR
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