QOL-15. THE PIVOTAL TRIDENT STUDY OF TUMOR TREATING FIELDS (TTFIELDS) THERAPY WITH CHEMORADIATION, FOLLOWED BY MAINTENANCE TTFIELDS THERAPY/TEMOZOLOMIDE (TMZ), IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM)
Bibliographic record
Abstract
Abstract INTRODUCTION: TTFields are electric fields which act to disrupt processes necessary for cancer cell division and tumor progression. TTFields therapy is a noninvasive, locoregional treatment with US FDA approval for ndGBM and recurrent GBM, as well as pleural mesothelioma. TTFields therapy concomitant with maintenance TMZ is standard of care in ndGBM after chemoradiation based on the pivotal EF-14 study (NCT00916409) reporting significant improvements in progression-free survival (PFS) and overall survival (OS) vs TMZ alone. Preclinical and pilot clinical studies subsequently demonstrated that concomitant TTFields therapy also enhanced the therapeutic effect of radiotherapy (RT). TRIAL DESIGN: TRIDENT (EF-32, NCT04471844) is a pivotal multicenter study investigating TTFields therapy (200 kHz) concomitant with RT/TMZ in adult patients with histologically confirmed ndGBM. Eligibility criteria include life expectancy (≥ 3 months) and Karnofsky performance status (≥ 70). Patients (n≈950) stratified by MGMT promoter methylation status and extent of resection are randomly assigned 1:1 to receive TTFields therapy from the first day of chemoradiation (experimental arm), or approximately 4 weeks after completion of chemoradiation (control arm). All patients will receive TTFields therapy uninterrupted for 24 months, or until second disease progression (PFS2). The primary endpoint is median OS and other endpoints include survival rates at 1 and 2 years, PFS (overall, PFS2, and rates at 6 and 12 months), overall radiological response, safety, quality of life and dependence of OS on TTFields dose. The sample size is powered for a hazard ratio of < 0.8 (5% type I error). A stratified log-rank test will be used to test the hypothesis that OS is significantly improved with first line TTFields therapy/RT/TMZ vs RT/TMZ. This global study is open at sites in 11 countries.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".