RBTT-08. EORTC 1709/CCTG CE.8: A PHASE III TRIAL OF MARIZOMIB IN COMBINATION WITH STANDARD TEMOZOLOMIDE-BASED RADIOCHEMOTHERAPY VERSUS STANDARD TEMOZOLOMIDE-BASED RADIOCHEMOTHERAPY ALONE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA
Bibliographic record
Abstract
The standard of care for patients with newly diagnosed glioblastoma includes maximum safe surgery, involved-field radiotherapy (RT), and concomitant and up to six cycles of maintenance temozolomide (TMZ) chemotherapy (TMZ/RT→TMZ). However, the prognosis remains poor and there is a high unmet need to provide new drugs to patients with glioblastoma. Marizomib is a novel, brain-penetrant irreversible pan-proteasome inhibitor that has been successfully assessed in phase I studies in patients with newly diagnosed as well as recurrent glioblastoma. EORTC 1709/CCTG CE.8 is a multicenter, randomized, controlled, open label phase III superiority trial. To be eligible, patients need to have histologically confirmed newly diagnosed glioblastoma. A total of 750 patients will be enrolled and randomized 1:1. Stratification factors include institution, age, Karnofsky performance status and extent of surgery. The primary objective of this study is to compare overall survival in patients receiving marizomib in addition to standard treatment (TMZ/RT→TMZ) with patients receiving standard treatment only. The testing strategy is defined to assess this objective in both the intent-to-treat population and the subgroup of patients with tumors harboring an unmethylated O6-methylguanine-DNA methyltransferase (MGMT) promoter. Secondary endpoints include progression-free survival, safety, neurocognitive function and quality of life. An accompanying translational research program has been set up. The study will be opened at 50 EORTC sites in Europe and done as an intergroup collaboration with the Canadian Cancer Trials Group (CCTG) with 25 sites in Canada and additional sites in the US. Patient enrolment is planned to start in June 2018 and an update on the enrolment status will be provided at the SNO conference. ClinicalTrials.gov Identifier: NCT03345095
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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 | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".