001053900 001__ 1053900 001053900 005__ 20260130163245.0 001053900 0247_ $$2doi$$a10.1093/neuonc/noaf201.0506 001053900 0247_ $$2ISSN$$a1522-8517 001053900 0247_ $$2ISSN$$a1523-5866 001053900 037__ $$aFZJ-2026-01598 001053900 082__ $$a610 001053900 1001_ $$0P:(DE-HGF)0$$aGeurts, Marjolein$$b0 001053900 1112_ $$a7th Quadrennial Meeting of the World Federation of Neuro-Oncology Societies$$cHonolulu$$d2025-11-20 - 2025-11-23$$gSNO / WFNOS 2025$$wUSA 001053900 245__ $$aCTNI-09. VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2/3 ASTROCYTOMA: STUDY PROTOCOL FOR THE PLACEBO-CONTROLLED, TRIPLE-BLIND, RANDOMIZED PHASE III STUDY EORTC-2427 (VIGOR) 001053900 260__ $$c2025 001053900 3367_ $$0PUB:(DE-HGF)1$$2PUB:(DE-HGF)$$aAbstract$$babstract$$mabstract$$s1769786867_27788 001053900 3367_ $$033$$2EndNote$$aConference Paper 001053900 3367_ $$2BibTeX$$aINPROCEEDINGS 001053900 3367_ $$2DRIVER$$aconferenceObject 001053900 3367_ $$2DataCite$$aOutput Types/Conference Abstract 001053900 3367_ $$2ORCID$$aOTHER 001053900 520__ $$aAbstractBACKGROUNDThe 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. 001053900 536__ $$0G:(DE-HGF)POF4-5253$$a5253 - Neuroimaging (POF4-525)$$cPOF4-525$$fPOF IV$$x0 001053900 588__ $$aDataset connected to CrossRef, Journals: juser.fz-juelich.de 001053900 7001_ $$0P:(DE-HGF)0$$aLeRhun, Emilie$$b1 001053900 7001_ $$0P:(DE-HGF)0$$aMinniti, Giuseppe$$b2 001053900 7001_ $$0P:(DE-HGF)0$$aPadovan, Marta$$b3 001053900 7001_ $$0P:(DE-HGF)0$$aDuerinck, Johnny$$b4 001053900 7001_ $$0P:(DE-HGF)0$$aFranceschi, Enrico$$b5 001053900 7001_ $$0P:(DE-HGF)0$$aTouat, Mehdi$$b6 001053900 7001_ $$0P:(DE-HGF)0$$aPace, Andrea$$b7 001053900 7001_ $$0P:(DE-HGF)0$$aSahm, Felix$$b8 001053900 7001_ $$0P:(DE-HGF)0$$aFurtner, Julia$$b9 001053900 7001_ $$0P:(DE-HGF)0$$aAlbert, Nathalie$$b10 001053900 7001_ $$0P:(DE-HGF)0$$aLohman, Philipp$$b11 001053900 7001_ $$0P:(DE-HGF)0$$avan Zandvoort, Martine$$b12 001053900 7001_ $$0P:(DE-HGF)0$$aQuoilin, Caroline$$b13 001053900 7001_ $$0P:(DE-HGF)0$$aDaumer, Corinne$$b14 001053900 7001_ $$0P:(DE-HGF)0$$aKoh, Eng-Siew$$b15 001053900 7001_ $$0P:(DE-HGF)0$$aPitz, Marshall$$b16 001053900 7001_ $$0P:(DE-HGF)0$$aGorlia, Thierry$$b17 001053900 7001_ $$0P:(DE-HGF)0$$aWeller, Michael$$b18 001053900 7001_ $$0P:(DE-HGF)0$$avan den Bent, Martin$$b19 001053900 7001_ $$0P:(DE-HGF)0$$aPreusser, Matthias$$b20 001053900 773__ $$0PERI:(DE-600)2094060-9$$a10.1093/neuonc/noaf201.0506$$gVol. 27, no. 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