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In the only prospective trial of chemotherapy then radiotherapy after surgery for gallbladder or bile duct cancer, two in three patients were alive at two years, including those whose cancer had reached the cut edge, but there was no comparison group.
S0809 enrolled patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma after radical resection with pT2 to 4, node-positive or margin-positive disease. Four cycles of gemcitabine and capecitabine were followed by capecitabine with radiotherapy (45 Gy to regional lymphatics, 54 to 59.4 Gy to the tumour bed). Of 79 eligible patients (68 percent cholangiocarcinoma, 32 percent gallbladder; 54 R0, 25 R1), 86 percent completed treatment. Two-year survival was 65 percent (95 percent CI 53 to 74): 67 percent after R0 and 60 percent after R1. Median overall survival was 35 months. Relapse was local in 14, distant in 24 and both in 9 patients. Grade 3 and 4 adverse effects occurred in 52 and 11 percent; one patient died of gastrointestinal haemorrhage.
This single-arm trial is why NCCN lists chemoradiation after a positive margin or involved nodes. The near-identical survival after R0 and R1 resection is suggestive but unproven; no randomised trial has followed, and the UK does not routinely offer it.
Shares A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Radiotherapy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares SWOG S0809, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Surgery and radiotherapy cure most, get least, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares Chemoradiation (chemoradiotherapy, CRT), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Capecitabine, Gallbladder cancer and the tag gallbladder-evidence.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.