# SWOG S0809

Source: https://onco.cc/trials/swog-s0809/  
OnCo record `swog-s0809` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Registry id: NCT00789958
- Phase: 2
- Setting: Adjuvant gemcitabine and capecitabine for four cycles followed by capecitabine with radiotherapy (45 Gy to regional nodes, 54 to 59.4 Gy to the tumour bed) after resection of pT2-4, node-positive or margin-positive extrahepatic cholangiocarcinoma or gallbladder carcinoma
- Sponsor: SWOG Cancer Research Network
- Enrolled: 105
- Result: 2-year OS 65% (R0 67%, R1 60%); median OS 35 months; grade 3 and 4 toxicity 52% and 11%.
- Outcomes: 2-year overall survival by margin: R0 67% vs R1 60%; Median overall survival: All eligible 35 months

## Notes

- 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.

## Sources

- ClinicalTrials.gov NCT00789958: https://clinicaltrials.gov/study/NCT00789958
- Ben-Josef et al., JCO 2015: SWOG S0809: https://doi.org/10.1200/JCO.2014.60.2219
- Adjuvant chemoradiation in resected biliary adenocarcinoma: evaluation of SWOG S0809 with a large national database (Ann Surg Oncol 2024): https://doi.org/10.1245/s10434-024-15117-y

## Connected records

- trials: [BILCAP](https://onco.cc/trials/bilcap/), [POLCAGB](https://onco.cc/trials/polcagb/)
- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- institutions: [SWOG Cancer Research Network](https://onco.cc/institutions/swog/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/), [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/), [Radiotherapy](https://onco.cc/terms/radiotherapy/)
- key papers: [Biliary Tract Cancers, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology](https://onco.cc/key-papers/paper-nccn-biliary-tract-cancers-v2-2025-jnccn-2025/), [Nomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer](https://onco.cc/key-papers/paper-wang-adjuvant-chemoradiotherapy-nomogram-gallbladder-cancer-jco-2011/), [SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma](https://onco.cc/key-papers/paper-swog-s0809-adjuvant-chemoradiation-jco-2015/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)
- ideas: [A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection](https://onco.cc/ideas/idea-gbc-randomised-adjuvant-chemoradiation-r1-node-positive/)

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