VIGOR (EORTC 2427-BTG)
Research type
Research Study
Full title
Vorasidenib as maintenance treatment after first-line chemoradiotherapy in IDH-mutant grade 2 or 3 astrocytoma: a placebo-controlled, triple-blind, randomized phase III study (VIGOR)
IRAS ID
1013477
Contact name
Eliza Starczewska
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Clinicaltrials.gov Identifier
Research summary
This study will test Vorasidenib on participants who have a brain tumour called IDH-mutant astrocytoma who have already undergone surgery, followed by radiotherapy and chemotherapy. Astrocytomas are a common type of brain tumour in both adults and children. They belong to a group of brain tumours called glioma.
Vorasidenib works by blocking the IDH-mutant protein in cancer cells, which may help slow down or stop the tumour from growing.
Once the initial treatment schedule is complete, the next step for the patient would usually be regular check-ups. We would like to find out if adding vorasidenib to the treatment schedule can reduce the chance of the tumour returning or getting worse.
In the US, EU and the UK, Vorasidenib is already approved for patients who only had surgery, we want to see if it is also an effective treatment for patients who also required chemotherapy and radiotherapy.
This study compares vorasidenib to a placebo, both patient groups will take a tablet every day starting after the end of radiotherapy and chemotherapy and continuing for up to 5 years. Therefore, the treatment duration is 5 years. The maximum amount of time on this study including follow-up is 10 years.
We will measure how long the treatment can keep patients alive and without the tumour progressing compared to the placebo. This is the main objective of the trial and is called progression free survival. Secondarily, we will also study other measures of efficacy like the response rate of the drug and the quality of life of patients under treatment, as well as measuring the safety of the treatment.
Why This Matters?
Currently, no additional treatment is given after radiotherapy and chemotherapy, even though tumours often return. If the study is positive, vorasidenib could become a new standard treatment, helping patients live longer while preserving brain function and quality of life.REC name
Wales REC 3
REC reference
26/WA/0073
Date of REC Opinion
9 Apr 2026
REC opinion
Further Information Favourable Opinion