P11.33.B Tumour Treating Fields (TTFields; 200 kHz) with chemo-radiation and maintenance TTFields/temozolomide as first-line treatment for newly-diagnosed glioblastoma: The phase 3 TRIDENT Trial (EF-32)
Bibliographic record
Abstract
Abstract Background Tumour Treating Fields therapy (TTFields; 200 kHz) is a noninvasive, loco-regional, antimitotic treatment approved for newly diagnosed glioblastoma (ndGBM) and mesothelioma. In the phase 3 EF-14 trial, TTFields/temozolomide (TMZ) significantly increased overall survival (OS) and progression-free survival (PFS) vs TMZ alone in patients with ndGBM. TTFields-related adverse events (AEs) were mainly dermatological with no increases in systemic toxicity. In preclinical models, the addition of TTFields to radiotherapy (RT) increased the therapeutic effect. In 2 clinical pilot phase 2 studies, TTFields added to RT/TMZ was reported as feasible and well-tolerated. Material and Methods TRIDENT (EF-32; NCT04471844) is an international, phase 3 randomised trial comparing TTFields (200 KHz, ≥ 18 h/day)/RT/TMZ vs RT/TMZ alone. Eligibility criteria include histologically confirmed ndGBM, ≥ 18 years of age (≥ 22 years of age; US), Karnofsky Performance Status ≥ 70, life expectancy ≥ 3 months, adequate organ function and eligible for RT/TMZ - participants will be stratified by extent-of-resection and O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status. During the initial 6-week investigational period, patients in the experimental arm will receive continuous TTFields and concomitant RT/TMZ whilst patients in the control arm will receive only RT/TMZ. Subsequently, all patients will receive TTFields and 6 cycles of maintenance TTFields/TMZ. TTFields will continue for 24 months or until second disease progression per Response Assessment in Neuro-Oncology (RANO), whichever occurs first. The primary endpoint is median OS. Secondary endpoints include median PFS (RANO), 1- and 2-year survival rates, overall radiological response (RANO), PFS6, PFS12, severity and frequency of AEs (Common Terminology Criteria for Adverse Events v5.0), post-treatment pathological changes in resected GBM tumours, quality-of-life per EORTC QLQ-C30, OS correlation to TTFields duration-of-usage, and neurological assessment per NANO (Neurological Assessment in Neuro-Oncology) and RANO criteria. Survival will be measured from time-of-randomisation. Sample size (N = 950; randomised 1:1) was powered for a hazard ratio < 0.8 with a 5% type I error. The hypothesis, that first-line TTFields/RT/TMZ can significantly improve OS vs RT/TMZ, will be tested using a stratified log-rank test. The study is currently open to enrollment in locations in Austria, Belgium, Czech Republic, France, Germany, Israel, Switzerland, and across the US.
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How this classification was reachedexpand
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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
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, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".