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The only prospective trial of chemotherapy followed by chemoradiotherapy after surgery for bile duct and gallbladder cancer: 79 patients, a third with gallbladder cancer, had two-year survival of 65 percent and median survival of 35 months, similar whether or not the margin was clear. It is the basis on which some centres offer radiotherapy after an R1 resection.
SWOG S0809 was a single-arm intergroup phase 2 for patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma after radical resection with pT2-4 stage, positive nodes or positive margins. Patients received four cycles of gemcitabine 1,000 mg/m² days 1 and 8 with capecitabine 1,500 mg/m² per day days 1 to 14 every 21 days, then concurrent capecitabine 1,330 mg/m² per day with radiotherapy of 45 Gy to the regional lymphatics and 54 to 59.4 Gy to the tumour bed. Of 79 eligible patients (R0 54, R1 25; extrahepatic cholangiocarcinoma 68 percent, gallbladder carcinoma 32 percent), 86 percent completed treatment. Two-year overall survival was 65 percent (95 percent confidence interval 53 to 74), 67 percent after R0 and 60 percent after R1 resection, and median overall survival was 35 months (R0 34, R1 35). Local, distant and combined relapse occurred in 14, 24 and 9 patients. Grade 3 and 4 adverse effects occurred in 52 and 11 percent (neutropenia 44 percent, hand-foot syndrome 11 percent, diarrhoea 8 percent) with one death from gastrointestinal haemorrhage. A 2024 National Cancer Database analysis of 4,997 patients meeting S0809 criteria found median survival of 36.9 months with chemoradiation and a propensity-matched hazard ratio of 0.86 against chemotherapy alone. No randomised trial has confirmed adjuvant chemoradiation in biliary cancer; in the UK it is not routine, and BILCAP capecitabine is the adjuvant standard, with chemoradiation considered case by case for R1 margins.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
NCCN is the source of the category grades quoted on the gallbladder cancer page; the adjuvant section leans on BILCAP for capecitabine and on SWOG S0809 for chemoradiation after margin-positive or node-positive resection.
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.
The observational basis, with SWOG S0809, for offering chemoradiation after node-positive or margin-positive resection in the United States. UK practice rarely does so; a randomised trial has never been run.
Shares Radiotherapy, Chemoradiation (chemoradiotherapy, CRT), Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares BILCAP, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Radiotherapy, Chemoradiation (chemoradiotherapy, CRT), Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares SWOG Cancer Research Network, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine.
Shares Radiotherapy, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Capecitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Capecitabine, Gemcitabine.