Initial feasibility and safety results from a phase II/III clinical trial to evaluate docetaxel (D) therapy in combination with zoledronic acid (ZA) ± strontium-89 (Sr89) in hormone-refractory prostate cancer patients: ISRCTN12808747.
Bibliographic record
Abstract
4677 Background: TRAPEZE is a four-arm seamless phase II/III randomised controlled trial of 3 licensed first-line treatments given in combination to hormone refractory prostate cancer (HRPC) metastatic to bone. Patients (pts) were randomised to receive 6 cycles of D and prednisolone with either: synchronous ZA, a single dose of Sr89 day 28 post-D; both; or neither. Further D could be given at the clinician's discretion. Recruitment is ongoing to the phase III part of the trial. Methods: This analysis includes 200 pts randomized to the phase II study. Primary outcome measures were feasibility, tolerability and safety; secondary outcomes included health economic comparisons, overall and disease-free survival. Results: Median age was 65 years (range 45-82); ECOG 0: 34% 1: 55% 2: 12%; 91% pts reported some degree of pain (median McGill-Melzack score 1.6). Median follow-up was 16.7 months (mo), median survival for all pts was 13.3 mo reflecting the advanced disease at entry. 29% of patients reported at least one grade 3 or 4 adverse event (AE), the most common being haematological, with no significant difference between trial arms. Mean number of D cycles received was 5 (median 6). 139/200 (70%) pts completed 6 cycles of therapy: main reasons for non-completion were disease progression (32/200, 16%) and toxicity (21/200, 11%). 73/101 patients allocated Sr89 reached cycle 6 of chemotherapy, 2 did not receive Sr89 due to early progression post-D. There were 2 SAEs related to Sr89. The 99 pts randomised to ZA received 498/511 possible cycles during D therapy: 3 pts discontinued, only 1 due to an AE (low calcium). Post-D 60% continued ZA. Conclusions: All four treatment arms are feasible, and no safety issues were identified in relation to using docetaxel, zoledronic acid and strontium-89 in combination. The trial has now entered phase III with the objective of determining the efficacy and cost-effectiveness of each of the experimental treatment arms compared to the control arm. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis
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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 | 0.007 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".