OSTWAL-2024-GEMCIS-CRT-GBC

Regimen

Experimental
Gemcitabine 1000 mg/m2 d1, d8 + cisplatin 25 mg/m2 d1, d8 q3w × 4 cycles, then concurrent chemoradiotherapy (50.4 Gy in 28 fractions with capecitabine 1500 mg/m2/day)
Control
Observation

Population

Resected gallbladder carcinoma (GBC only) with high-risk features (T3-T4 or node-positive or R1), India single-institution (Tata Memorial Hospital, Mumbai); all Indian patients; GBC is endemic in Northern/Eastern India

Key finding

This is the first randomized trial to show a significant DFS benefit with adjuvant GemCis followed by CRT specifically in high-risk GBC — a subtype with historically dismal outcomes after resection. The 14-month DFS improvement is clinically meaningful. The trial is unique in its sequential chemo-then-CRT design and its GBC-only population, which is highly relevant given India's high GBC incidence. Limitations include single-center design and an Indian-specific patient population; generalizability to other regions is uncertain. OS data at time of primary publication showed a trend but were immature.

Source: PMID 38958997

Timeline

    Guideline citations

    • NCCN BTC (p.6)