RTHP-05. INTRAOPERATIVE RADIOTHERAPY (IORT) USING LOW-ENERGY X-RAYS IN A COHORT OF PREDOMINANTLY INCOMPLETELY RESECTED NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (INTRAGO TRIAL)
Bibliographic record
Abstract
Local recurrence remains the predominant pattern of failure in glioblastoma multiforme (GBM), indicating that residual clonogenic tumor cells may need to be targeted by more intensive therapy of the tumor cavity. We performed a phase I/II trial (NCT02104882) to evaluate safety and tolerability of intraoperative radiotherapy (IORT) with 20-40 Gy of low-energy photons (50 kV) in addition to standard radiochemotherapy. The primary endpoint was occurrence of dose-limiting toxicities (DLT) within 3 months after IORT (wound healing deficits, cerebral bleeding/ischemia, brain necrosis and early termination of radiochemotherapy). Secondary endpoints were progression-free survival (PFS), local PFS (≤ 1cm to the cavity) and overall survival (OS). Fourteen patients with histologically confirmed IDH1wt GBM were included (median FU 12.4 months), 12 underwent incomplete resection, 9 had unmethylated MGMT promoters, 6 had unresectable satellites and 3 did not receive per-protocol treatment (PPT). No DLTs were observed at any dose level within the predefined time frame. The majority of grade 3-5 adverse events (21 of 25) were deemed related to chemotherapy or tumor progression. Radionecrosis was diagnosed in 3 patients which occurred after the predefined time frame. The median PFS was 10.3 months (95%CI: 5.2-15.4) in all and 11.4 months (95%CI: 9.8-13.0) in PPT patients. The median local PFS was 13.4 m (95%CI: 9.7-17.1) in all and 14.5 m (95%CI: 11.3-17.7) in PPT patients. The median OS was 14.5 m (95%CI: 9.8-19.2) for all and 16.5 m (95%CI: 11.5-21.5) for PPT patients. One distant response was observed without any change of treatment. IORT with low-energy photons in addition to standard therapy is safe and tolerable. Despite multiple poor prognostic factors, median and local PFS compare favourably to historic data (mPFS was 6.9 m in the EORTC/NCIC trial). The technique is now tested in a multinational randomized phase III trial (NCT02685605).
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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 | 0.001 |
| 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 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".