A multicenter randomized phase II trial comparing nab-paclitaxel to paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen: NCIC Clinical Trials Group BL 12 (NCT02033993).
Bibliographic record
Abstract
TPS4573 Background: Metastatic urothelial cancer remains an incurable disease, for which there is no standard second line treatment. A previous phase II study of nab-paclitaxel in this setting demonstrated activity and good tolerability. The current study is designed to characterize the activity of nab-paclitaxel compared to paclitaxel in the second line treatment setting for advanced urothelial cancer. Methods: This is an NCIC Clinical Trials Group (NCIC CTG) led intergroup trial with the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The primary objective is to compare the progression free survival (PFS) between the two arms. Secondary objectives include: objective response rate, clinical benefit rate, time to response, response duration, toxicity, quality of life, and cost effectiveness. Correlative biological studies relating to tissue predictive and prognostic biomarkers and pharmacogenomics will be conducted. Clinicodemographic factors will be prospectively collected using a health and demographic questionnaire to further understand the relationships between biomarkers and clinical outcome measures. Statistical Design: Planned accrual is 199 patients over 3 years with followup of 4 months. Assuming median PFS of 4 months with paclitaxel, the target hazard ratio is 0.67 (PFS of 4 mo vs. 6 months, 1-sided, 5% significance with 80% power). Estimated sample size accounts for loss to followup or withdrawal of consent. Conduct to Date: Study activation: Mar 2014 (NCIC), Feb 2015 (ANZUP). As of February 2 2015, current accrual is 38. In November 2014 an independent DSMC recommended trial continuation. Supported by Celgene Corporation Clinical trial information: NCT02033993.
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 | 0.004 | 0.004 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.015 | 0.002 |
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".