EORTC-2427-BTG: 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)

Condition studied

​​IDH-mutant grade 2 or 3 astrocytoma​

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint is PFS, as assessed locally from the date of enrolment using the RANO 2.0 criteria.

Endpoint detail

PFS by retrospective central radiological assessment from the date of enrolment using the RANO 2.0 criteria., PFS from the start of radiotherapy (both local and retrospective central radiological assessment) using RANO 2.0 criteria., OS from date of enrolment., Best response, overall response, disease control and complete response rate (both local and retrospective central radiological assessment) as well as duration of response using RANO 2.0 criteria., TTNI, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0., HRQoL will be assessed, Neurological symptoms and signs, assessed using the NANO scale and measured by neurological progression-free survival (NPFS) and Seizure Control Composite Score Index., Neurocognitive function, as assessed by a test battery consisting of HVLT-R, TMT, COWA test, and MOS scale