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)
Bibliographic record
Abstract
Abstract BACKGROUND The 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 METHODS VIGOR 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). CONCLUSION VIGOR (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 REGISTRATION 2024-519404-27-00 (EudraCT-number). FUNDING Servier.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | low |
| gpt | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | high |
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.006 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.004 | 0.001 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.034 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedLabeled directly by 2 models reading the full record.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".