RAVINA (EORTC 2120-HNCG)
Research type
Research Study
Full title
Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study: RAVINA
IRAS ID
1007846
Contact name
Lore Hermans
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Clinicaltrials.gov Identifier
Research summary
This study is for elderly adults who have been diagnosed with head and neck cancer that can be treated with radiotherapy. The standard treatment that is currently given is radiotherapy on its own. In this study we will combine radiotherapy with a new drug called xevinapant and compare this treatment with radiotherapy on its own.
A recent study that combined xevinapant with chemotherapy and radiotherapy has shown promising results with the cancer coming back less often and participants surviving for longer. However, there is no clear survival benefit of giving chemotherapy to participants over 70 years of age and the side effects can impact on their quality of life. Early research studies suggest that xevinapant combined with radiotherapy can control the disease for longer and the side effects are tolerated better than chemotherapy. This means that people are more likely to be able to perform their daily activities and have a better quality of life. However, there is no conclusive proof of this yet, which is why this study is being done.
We will look at the safety and tolerability of this treatment combination and the effect on the participants’ health and quality of life. In this study the benefit is also measured by the length of time that participants live with the disease without it coming back (Event-free Survival).
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
London - Central Research Ethics Committee
REC reference
23/LO/0839
Date of REC Opinion
9 Nov 2023
REC opinion
Further Information Favourable Opinion