A randomized phase II/III study comparing stereotactic body radiotherapy (SBRT) versus conventional palliative radiotherapy (CRT) for patients with spinal metastases (NCT02512965).
Bibliographic record
Abstract
TPS10129 Background: Innovative radiotherapy technology and modern imaging capabilities enable the use of Stereotactic Body Radiotherapy (SBRT) to treat patients with spinal metastases to optimize tumour control and palliation compared to standard conventional radiotherapy. No randomized clinical trial evidence exists directly comparing the two treatment strategies. Methods: SC.24 is a Canadian Cancer Trials Group randomized phase II/III study comparing standard conventional radiotherapy (20 Gy/5fr) to SBRT (24 Gy/2fr) in patients with solid tumours and MRI documented, painful spinal metastases suitable for RT. The primary accrual objective for the phase II portion of the study was met in January 2017 and the study continues as a randomized phase III study with a primary outcome measure of complete pain response at 3 months post radiotherapy. Secondary objectives include: measurement of complete pain response at 6 months; radiation site progression free survival at 3 and 6 months; adverse event profile, health related QOL and compliance with RT QA measures. Biobanking for future correlative studies is included in study design. Statistical design: The statistical assumptions for the phase III study include estimated complete pain response rates of 10% and 30% for the CRT and SBRT treatment arms respectively. Using a two sided alpha = 0.05 and power = 80% the sample size for the phase III study is 152, taking into account a 5% drop out rate. Conduct to Date: Study activation: July 2015. Accrual to date: 58. Supported by CCSRI grant 021039 Clinical trial information: NCT02512965.
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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 | 0.005 | 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 | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.033 | 0.004 |
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".