Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy.
Bibliographic record
Abstract
Background Current radiotherapy treatment techniques for head and neck cancer use closed thermoplastic masks to ensure accurate and effective immobilization. Patients often tolerate these masks poorly, and many experience symptoms of claustrophobia and distress. This prospective randomized controlled Phase III trial has been developed to compare the setup accuracy and patient experience between three types of masks for head and neck cancer patients: standard closed 5 points, open 5 points, and open 3 point radiotherapy masks. Methods The study will be conducted across a 3 site radiotherapy network, including 201 patients. Patients will be randomised into three arms on a 1:1:1 basis. The inclusion criteria will be all patients undergoing radical radiotherapy of 30-35 fraction duration for head and neck cancer. To ensure daily set up accuracy and patient safety, patients on all three arms will be imaged daily with cone beam CT (CBCT). Surface-guided technology will be used for open arms measuring both inter- and intrafraction motion. Patient distress and experience with masks will be evaluated through a GHQ 12 questionnaire and questions on their perceptions. Discussion Studies have demonstrated the safety of open masks when combined with surface-guided technology to maintain adequate setup accuracy for treatment delivery. The reduced surface in contact with the patient requires robust evaluation to ensure effective immobilization. An earlier study in claustrophobic patients was conducted; however, open masks were not evaluated in a large randomized trial for patients without claustrophobia. The overall purpose of the trial was to evaluate whether open face masks in conjunction with modern treatment verification technology should be the new standard of care, providing safe and effective immobilization and better treatment experience for all patients undergoing head and neck radiotherapy. Trial Registration CTI 23-24, Caner Trials Ireland January 24 https://www.cancertrials.ie/cti-trials/open/ NCT06327139 January 2024 https://clinicaltrials.gov/ct2/show/NCT06327139/
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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 | 0.008 | 0.009 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.041 | 0.006 |
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".