SWOG-S0809

NCT00789958 📎

Regimen

Experimental
Gemcitabine 1000 mg/m2 d1, d8 + capecitabine 1500 mg/m2/day d1-14 q3w × 4 cycles, then capecitabine 1330 mg/m2/day concurrent with radiotherapy (54 Gy in 28 fractions to tumor bed ± regional nodes)
Control
single-arm / no comparator

Population

Resected extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), stages T2-T4 or node-positive; US multicenter (SWOG intergroup); ECC ~54%, GBC ~46%

Key finding

SWOG S0809 demonstrated that sequential chemo-CRT is feasible and active after resection of ECC and GBC, with 2-year OS exceeding the pre-specified 60% threshold. The trial is single-arm phase 2 and cannot establish superiority over chemotherapy alone, but remains the largest prospective dataset for adjuvant CRT in extrahepatic BTC. R1 resection patients showed numerically comparable outcomes to R0, suggesting CRT may compensate for microscopic residual disease. Toxicity was manageable, with grade 3-4 events in ~52% but limited grade 4.

Source: PMID 25964250

Timeline

    Guideline citations

    • NCCN BTC (p.39)