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@INPROCEEDINGS{Geurts:1053900,
author = {Geurts, Marjolein and LeRhun, Emilie and Minniti, Giuseppe
and Padovan, Marta and Duerinck, Johnny and Franceschi,
Enrico and Touat, Mehdi and Pace, Andrea and Sahm, Felix and
Furtner, Julia and Albert, Nathalie and Lohman, Philipp and
van Zandvoort, Martine and Quoilin, Caroline and Daumer,
Corinne and Koh, Eng-Siew and Pitz, Marshall and Gorlia,
Thierry and Weller, Michael and van den Bent, Martin and
Preusser, Matthias},
title = {{CTNI}-09. {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})},
issn = {1523-5866},
reportid = {FZJ-2026-01598},
year = {2025},
abstract = {AbstractBACKGROUNDThe efficacy of vorasidenib as
maintenance therapy after completion of standard of care
remains unclear. The VIGOR trial will investigate the
efficacy of adding vorasidenib as maintenance therapy after
completion of standard radiochemotherapy in patients with
astrocytoma, IDH-mutant, WHO grade 2 or 3.MATERIAL AND
METHODSVIGOR is a comparative, randomized (1:1),
triple-blinded, multicentre phase III superiority trial. A
total of 468 adult patients with an astrocytoma, IDH-mutant,
WHO grade 2 or 3, at least one prior neurosurgery, who were
in need for radiochemotherapy and completed standard of care
radiotherapy followed by chemotherapy will be randomized
between placebo or vorasidenib monotherapy 40 mg once daily
until disease progression, unacceptable toxicity, or
withdrawal of patient consent for up to 5 years. The primary
objective is to demonstrate that vorasidenib maintenance
therapy improves locally assessed PFS from enrolment
compared to placebo. Primary endpoint is PFS from
randomization, patients are randomized upon completion of
the adjuvant chemotherapy. Secondary endpoints include PFS
from start of radiotherapy, overall survival, time to next
intervention, toxicity, health related quality of life,
neurological symptoms and neurocognitive function.
Translational research including tissue samples, liquid
biopsies, and neuroimaging data is planned. Patients will be
enrolled in 10 European countries (European Organisation for
Research and Treatment of Cancer (EORTC) sites), Australia
(Cooperative Trials Group for Neuro-Oncology (COGNO) sites)
and Canada (Canadian Cancer Trials Group (CCTG) sites).
Trial activation is planned for December 2025. The inclusion
duration is 3 years, total study duration is approximately
130 months (10.8 years).CONCLUSIONVIGOR (EORTC-2427-BTG)
will investigate the efficacy and safety of adding
maintenance vorasidenib after completion of
radiochemotherapy in patients with newly diagnosed
astrocytoma, IDH-mutant, WHO grade 2 or 3. If the trial is
positive, this has the potential to become a new standard of
care.CLINICAL TRIAL REGISTRATION2024-519404-27-00
(EudraCT-number).FUNDINGServier.},
month = {Nov},
date = {2025-11-20},
organization = {7th Quadrennial Meeting of the World
Federation of Neuro-Oncology Societies,
Honolulu (USA), 20 Nov 2025 - 23 Nov
2025},
cin = {INM-4},
ddc = {610},
cid = {I:(DE-Juel1)INM-4-20090406},
pnm = {5253 - Neuroimaging (POF4-525)},
pid = {G:(DE-HGF)POF4-5253},
typ = {PUB:(DE-HGF)1},
doi = {10.1093/neuonc/noaf201.0506},
url = {https://juser.fz-juelich.de/record/1053900},
}