SWOG S0809: A phase II trial of adjuvant capecitabine (cap)/gemcitabine (gem) followed by concurrent capecitabine and radiotherapy in extrahepatic cholangiocarcinoma (EHCC) and gallbladder carcinoma (GBCA).

4030 Background: The role of adjuvant therapy after resection of EHCC or GBCA is unknown. S0809 was designed to estimate the stratum-specific (R0 and R1) and overall 2-year survival (OS), overall disease-free survival (DFS), local relapse (LR), and toxicity in patients (pts) treated with this adjuvant regimen. Methods: Eligibility included tissue diagnosis of EHCC or GBCA s/p radical resection, pT2-4, N+ or R1, M0, and PS 0-1. Pts received 4 cycles of gem (1 g/m2 IV, d1, d8) and cap (1500 mg/m2/d, days 1-14) q 21 days followed by concurrent cap (1330 mg/m2/d) and radiation (45 Gy to regional lymphatics and 54-59.4 Gy to the tumor bed). A total of 80 evaluable pts were needed; results would be considered promising if the 95% confidence interval (CI) for 2-year OS excluded a rate <45% and if the stratum specific point estimates were ≥65% for R0 and ≥45% for R1. Central pathology and radiation therapy reviews were performed. Results: 79 evaluable pts (54 R0, 25 R1) were registered; median age 62 yrs, 52% wom...