A phase III randomized controlled trial comparing palliative stereotactic body radiotherapy vs. palliative standard radiotherapy in patients with advanced head and neck cancer (NCT06641791).
Bibliographic record
Abstract
TPS6118 Background: The optimal radiotherapy (RT) treatment regimen for patients with advanced head and neck cancer (AHNC) unsuitable to receive curative intent RT is undefined. Stereotactic body radiotherapy (SBRT) is a promising technique but rigorous multicentre evaluation is required prior to adoption. Methods: This is a Phase III randomized controlled trial comparing palliative SBRT to palliative standard RT (SRT) in participants with advanced mucosal, squamous cell head and neck cancer unable to tolerate curative intent RT. Key eligibility criteria: Unsuitable for curative intent therapy, no evidence of metastatic disease, stages TX or T0-T4/N0-N3, geriatric 8 score [1] ≤14. Treatment arms: (Experimental) SBRT 4500 cGy/ 5fr (twice a week to primary and nodal GTV (BED 10 85) OR 4000 cGy /5 fr twice a week if organs at risk (BED 10 -72) versus (standard) 2400 cGy/ 3fr (day 0/7/21 (BED 10 43) or 2500 cGy/ 5fr over 1 week (BED 10 38). Primary objective: To compare OS between arms. Secondary objectives evaluate progression-free survival (PFS), locoregional failure-free survival, distant metastases-free survival, response rates, acute and long-term toxicity (CTCAE v5.0), treatment compliance, patient-reported outcomes (PRO-CTCAE, FACT-HN), resource utilization, and health utilities. Statistical design : The trial aims to enroll 196 patients with a 2:1 randomization ratio (SBRT:SRT). The study is powered at 80% with a two-sided alpha of 0.05 to detect a difference in 1-year OS of 40.3% vs. 22% (HR = 0.6), assuming a 15% drop-out/lost to follow-up rate. Conduct to Date : This trial was activated on October 31, 2024. Supported by CCS grant #707213; CIHR #175014. [1] Takahashi M, Takahashi M, Komine K, Yamada H, Kasahara Y, Chikamatsu S, et al. (2017) The G8 screening tool enhances prognostic value to ECOG performance status in elderly cancer patients: A retrospective, single institutional study. PLoS ONE 12(6): e0179694. https://doi.org/10.1371/journal.pone.0179694. Clinical trial information: NCT06641791 .
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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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.029 | 0.003 |
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".