Executive Summary

Phase III RCT abstract (missing: pre-specified non-inferiority margin, OS results, absolute toxicity rates, power calculation vs. enrollment). No-go; reversal requires a powered non-inferiority RCT with OS as the primary endpoint and a pre-registered equivalence margin.

Top 3 Action Items

1. CRITICAL (Confidence: 92) — Retrieve trial registration GCIG/KGOG 1027/THAI 2012; if no non-inferiority margin is registered, the "feasible alternative" conclusion is formally invalid.
2. CRITICAL (Confidence: 88) — Obtain full publication OS data; net patient harm cannot be excluded without survival event counts.
3. IMPORTANT (Confidence: 80) — Quantify chemotherapy-delay confounding analytically; the RFS gap (78.7% vs. 84.1%) may reflect adherence disparity, not pharmacology.

Biggest Risk

The trial's superiority design failed (P=0.28), yet Section 8 endorses tri-weekly as equivalent — a claim requiring a pre-specified non-inferiority margin that Section 6 confirms was never set. Confidence: 90/100. The HR 95% CI of 0.39–1.32 permits a 32% survival harm; practice change based on this trial could injure patients.

Next Step

Lead oncologist: 2 hours — retrieve registration record and full OS Kaplan-Meier data.