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)

Conditions

IDH-mutant grade 2 or 3 astrocytoma

Brief summary

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

Detailed description

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

Marjolein Geurts, Emilie LeRhun, Giuseppe Minniti, Marta Padovan, Johnny Duerinck et al. (21 authors)

Neuro-Oncology2025-11-01

10.1093/neuonc/noaf201.0506

P17.06.A VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2/3 ASTROCYTOMA: STUDY PROTOCOL FOR THE PLACEBO-CONTROLLED, TRIPLE-BLIND, RANDOMIZED PHASE III STUDY EORTC-2427 (VIGOR)

Marjolein Geurts, Émilie Le Rhun, Giuseppe Minniti, Matteo Padovan, Johnny Duerinck et al. (21 authors)

Neuro-Oncology2025-10-01

10.1093/neuonc/noaf193.522

Interventions

DRUGS95032/AG-881

DRUGPlacebo tablets to match S95032 drug product are supplied as film-coated tablets for oral administration.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed