SWOG S0809
The only prospective trial of chemotherapy followed by radiotherapy after gallbladder or bile duct surgery: two in three patients were alive at two years, even when the margin had been involved, but with no comparison group the benefit is unproven.
Overview
S0809 treated 79 eligible patients (68 percent extrahepatic cholangiocarcinoma, 32 percent gallbladder cancer; 54 R0, 25 R1) with four cycles of gemcitabine and capecitabine followed by 45 Gy to the regional nodes and 54 to 59.4 Gy to the tumour bed with concurrent capecitabine. Two-year survival was 65 percent (95 percent CI 53 to 74), 67 percent after R0 and 60 percent after R1 resection; median overall survival was 35 months. Grade 3 and 4 adverse effects occurred in 52 and 11 percent. It is the evidence behind guideline options for chemoradiation after R1 or node-positive resection, and no phase 3 has followed it.
- 65 vs 67 out of 100 alive with Gemcitabine-capecitabine then chemoradiation (all) compared with R0 subgroup; 2 fewer per 100.
- On this measure the first group did worse, not better.
- Other groups: R1 subgroup 60 of 100.
- 67 vs 60 out of 100 alive at 2 years with R0 compared with R1; 7 more per 100.
- Roughly one extra person helped for every 14 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Median 35 months with All eligible.
- A median is a midpoint: half the people did better than this and half did worse.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Resected extrahepatic cholangiocarcinoma or gallbladder cancer (pT2 to 4, node-positive or margin-positive): adjuvant gemcitabine-capecitabine then capecitabine with radiotherapy. People in a different situation may not see the same effect.
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.
105 enrolled.
Notes
top- Key figures: 79 eligible (R0 54, R1 25; extrahepatic cholangiocarcinoma 68 percent, gallbladder carcinoma 32 percent); two-year overall survival 65 percent (53 to 74), 67 percent after R0 and 60 percent after R1; median overall survival 35 months; grade 3 and 4 adverse effects 52 and 11 percent with one death from gastrointestinal haemorrhage. A 2024 National Cancer Database analysis of 4,997 S0809-eligible patients found median survival of 36.9 months with chemoradiation (hazard ratio 0.86 against chemotherapy alone, propensity matched). Not routine in the UK; considered case by case after an R1 margin.
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.
Similar pages
not linked directly; found by shared links- Key paperNomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer
Shares SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma, A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Radiotherapy, Chemoradiation (chemoradiotherapy, CRT) and the tag gallbladder-evidence.
- TrialACTICCA-1
Shares BILCAP, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Capecitabine and the tag gallbladder-evidence.
- Key paperValidation of the 8th Edition American Joint Commission on Cancer (AJCC) Gallbladder Cancer Staging System: Prognostic Discrimination and Identification of Key Predictive Factors
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.
- Key paperA phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol
Shares POLCAGB, Chemoradiation (chemoradiotherapy, CRT), Gallbladder cancer and the tag gallbladder-evidence.
- Key paperSurgical outcomes in gallbladder cancer: evidence from the UK nationwide CAPBIL study
Shares BILCAP, 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.
- TrialGAIN (AIO/CALGP/ACO)
Shares 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), Gemcitabine, Biliary tract cancer (cholangiocarcinoma) and the tag gallbladder-evidence.
- TrialHERIZON-BTC-01
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 in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma) and the tag gallbladder-evidence.
- TrialNIFTY
Shares 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), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag gallbladder-evidence.