ATCT-16CODEL (ALLIANCE-N0577; EORTC-26081/2208; NRG-1071; NCIC-CEC-2): PHASE III RANDOMIZED STUDY OF RT VS. RT + TMZ VS. TMZ FOR NEWLY DIAGNOSED 1p/19q-CODELETED ANAPLASTIC GLIOMA. ANALYSIS OF PATIENTS TREATED ON THE ORIGINAL PROTOCOL DESIGN
Bibliographic record
Abstract
BACKGROUND: CODEL originally included an RT-alone control arm. Following EORTC 26951/RTOG 9402 reports, the original study closed for revision of the control arm to RT + adjuvant PCV. We performed an analysis of pts randomized per the original CODEL design. METHODS: Adults (>18 yr) with newly diagnosed, 1p/19q codeleted WHO grade III anaplastic glioma were randomized to RT (5940 cGy) (Arm A); vs. RT + TMZ (75mg/M2/D +RT; 150-200mg/M2, D1-5 q28D X 6-12 (Arm B); vs. TMZ (150-200 mg/M2, D1-5q28D X 12 (Arm C). Stratification included Age (< or>50); Group [North America vs EORTC]; and ECOG status (0-1 vs. 2). Primary endpoint was overall survival. PFS was compared by logrank test (Arm C vs. Arms A + B (pooled). RESULTS: 36 pts (N.A.-53%, EORTC-47%) were randomized (Arm A-12; Arm B-12; Arm C-12), with balance for age, ECOG status, and extent of resection. Grade 3+ toxicity occurred in 25%, 41% and 31% (Arms A, B and C, respectively). No pts withdrew or died from toxicity. All treatment cycles were completed in 92%, 83% and 58% (Arms A, B and C, respectively). Progression during treatment occurred in 5/12 (42%) TMZ alone pts, vs. 0/24 (0%) on RT arms. With median follow-up of 3.4 yrs, 6/12(50%) of the TMZ alone pts have progressed, vs. 2/24(8%) on RT Arms (p = 0.002); death from disease progression occurred in 5%(3/12) TMZ alone pts vs. 4% (1/24) on RT Arms (A-0; B-1). Median PFS was 2.5 yr for TMZ alone vs. not reached for pts on RT Arms. CONCLUSIONS: In this preliminary analysis, patients receiving TMZ alone experienced shorter PFS and time to death from tumor progression, compared to those receiving RT alone or RT + TMZ. Accordingly, the Alliance DSMC recommended closure of Arm C. CODEL has been revised to a two-arm comparison of RT + adjuvant PCV vs. RT + concomitant/adjuvant TMZ. (Support: U10CA180821)
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".