A randomized phase III study in advanced esophageal cancer (OC) to compare the quality of life (QoL) and palliation of dysphagia in patients treated with radiotherapy (RT) or chemoradiotherapy (CRT) TROG 03.01 NCIC CTG ES.2.
Bibliographic record
Abstract
4009 Background: RT is known to relieve dysphagia of advanced oesophageal cancer, there is no data from randomised phase III trials determining response, toxicity, or role of palliative CRT. Aims 1) to establish effective and least toxic treatment for symptom relief of advanced OC 2) determine effects of common cancer treatments on QoL and end of life care 3) establish an evidence base for patient decision making regarding the optimal management for incurable OC. Methods: 220 patients were randomised to receive a course of palliative RT [35 Gy in 15 fractions, (n=115) or 30 Gy in 10 fractions (n=105) in Canada and UK], or concomitant CRT with Cisplatin and 5FU (D1-4) (n=111). Dysphagia was measured using the Mellow score, toxicity using CTCAE v2, and QoL using EORTC QLQ30 and oesophagus module (OES-18). The primary end point was the proportion of patients with improved dysphagia as measured at week 9 and maintained until week 13. Results: The patients receiving radiotherapy alone showed a dysphagia response (at any point) of 67.89% compared to chemotherapy response in 73.87%, this was not a significant difference (p=0.343). There was increased toxicity in patients receiving CRT, with worse bowel conditions (nausea (p=0.0019) and vomiting (p=0.0072)). The median survival was 210 days for CRT and 203 days for RT alone. The baseline parameters of both groups were well matched at randomisation and although the results of the trial showed equally poor survival prognosis in both arms, there were some patients (n=21) still alive at 2 years post treatment. Conclusions: Although the CRT group had slightly better dysphagia response and median survival, the bowel toxicity was worse. Further analysis of QoL, toxicity and durable palliative response will be published. This multicentre trial, conducted in the UK, Canada, Australia and New Zealand reflects practice in several countries RT alone remains an excellent tool for palliation of patients with advanced OC and should remain the standard of care. Clinical trial information: NCT00193882.
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 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".