Abstract CT258: EF-32 (TRIDENT): A pivotal randomized trial of radiation therapy concomitant with temozolomide +/- Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma
Bibliographic record
Abstract
Abstract Purpose: Tumor treating fields (TTFields) is a non-invasive, loco-regional antimitotic treatment approved as a standard-of-care for newly diagnosed glioblastoma (ndGBM). In the Phase 3 EF-14 trial, TTFields (200 kHz) plus temozolomide (TMZ) post-surgery and chemoradiation significantly increased survival of ndGBM patients compared to TMZ alone. The addition of TTFields was not associated with any increases in systemic toxicity. TTFields-related adverse events (AEs) were mainly dermatological. In preclinical models, TTFields increase the therapeutic effects of radiation therapy (RT). A pilot study showed that TTFields concomitant with RT and TMZ is well tolerated. The benefit of TTFields concomitant with RT and TMZ will be investigated in the TRIDENT trial. Methodology: TRIDENT (NCT04471844) is an international, pivotal randomized trial comparing standard RT with concomitant TMZ vs the triple combination of RT with concomitant TMZ and TTFields. RT is delivered through the TTFields transducer arrays. Patients in both arms will receive maintenance TTFields and TMZ. TTFields (200 KHz) will be delivered >18 hours/day using the Optune device. TTFields treatment will be continued until the second disease recurrence. Patients with pathologically confirmed ndGBM, ≥ 18 years (≥ 22 years in the US), KPS ≥ 70, either sex, post-surgery or biopsy, and candidates for RT/TMZ therapy will be stratified by extent of resection and MGMT promoter methylation status. The primary endpoint is overall survival (OS). Secondary end points include progression free survival (PFS; RANO), 1- and 2-year survival rates, overall radiological response (ORR; RANO), PFS (PFS6M, PF12M, PFS2Y); severity and frequency of AEs (CTCAE V5.0); pathological changes in resected GBM tumors post treatment; quality of life (EORTC QLQ-C30); and correlation of OS to TTFields compliance. The hypothesis is that concomitant TTFields/RT/TMZ will significantly improve OS versus RT/TMZ. Sample size (N=950; 475/arm) will detect a HR< 0.8 with 5% type I error. Survival will be measured from the time of randomization until date of death. At the time of analysis, patients lost to follow-up or still on protocol follow-up will be censored at the last date known to be alive. The TRIDENT trial is currently enrolling patients. Citation Format: Wenyin Shi, Lawrence Kleinberg, Suriya A. Jeyapalan, Samuel A. Goldlust, Seema Nagpal, Stephanie E. Combs, David Roberge, Ryo Nishigawa, Rachel Grossman, Martin Glas. EF-32 (TRIDENT): A pivotal randomized trial of radiation therapy concomitant with temozolomide +/- Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT258.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".