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← Bile Duct Cancer (Cholangiocarcinoma)

HEALTH PROFESSIONAL · SOURCE READING

External-beam radiation therapy (EBRT)

Source: Bile Duct Cancer (Cholangiocarcinoma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: March 28, 2025 · Captured 2026-09-09.

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Context: Treatment of Resectable (Localized) Bile Duct Cancer / Treatment Options for Resectable (Localized) Bile Duct Cancer / Adjuvant therapy

Numerous retrospective studies have suggested that adding EBRT after complete surgical resection may be beneficial.[19,20][Level of evidence A1] However, no prospective randomized trials have demonstrated an OS benefit.

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Evidence (EBRT):

One small randomized trial of 207 patients with pancreatic and periampullary cancers demonstrated no survival benefit of adding chemoradiation therapy after surgery. This study had limitations: only a few patients had a diagnosis of bile duct cancer, and 20% of the patients randomly assigned to receive chemoradiation therapy did not receive treatment.[21][Level of evidence C3]

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A phase II cooperative group trial, SWOG S0809 (NCT00789958), evaluated adjuvant capecitabine and gemcitabine followed by chemoradiation therapy for resected extrahepatic cholangiocarcinoma and gallbladder cancer. In total, 79 eligible patients with pT2 to pT4 disease, node-positive disease, or positive-margin resection were enrolled (extrahepatic bile duct cancer, n = 54; gallbladder cancer, n = 25).[22][Level of evidence C2]

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A phase II cooperative group trial, SWOG S0809 (NCT00789958), evaluated adjuvant capecitabine and gemcitabine followed by chemoradiation therapy for resected extrahepatic cholangiocarcinoma and gallbladder cancer. In total, 79 eligible patients with pT2 to pT4 disease, node-positive disease, or positive-margin resection were enrolled (extrahepatic bile duct cancer, n = 54; gallbladder cancer, n = 25).[22][Level of evidence C2]

The 2-year survival rate of 65% was significantly higher than expected, based on historical controls.[22][Level of evidence C2]

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A phase II cooperative group trial, SWOG S0809 (NCT00789958), evaluated adjuvant capecitabine and gemcitabine followed by chemoradiation therapy for resected extrahepatic cholangiocarcinoma and gallbladder cancer. In total, 79 eligible patients with pT2 to pT4 disease, node-positive disease, or positive-margin resection were enrolled (extrahepatic bile duct cancer, n = 54; gallbladder cancer, n = 25).[22][Level of evidence C2]

Grade 3 toxicity was observed in 52% of patients, and grade 4 toxicity was observed in 11% of patients.

A phase II cooperative group trial, SWOG S0809 (NCT00789958), evaluated adjuvant capecitabine and gemcitabine followed by chemoradiation therapy for resected extrahepatic cholangiocarcinoma and gallbladder cancer. In total, 79 eligible patients with pT2 to pT4 disease, node-positive disease, or positive-margin resection were enrolled (extrahepatic bile duct cancer, n = 54; gallbladder cancer, n = 25).[22][Level of evidence C2]

Based on these results, this regimen was observed to be well tolerated, but it needs to be tested in a randomized controlled trial.

All patients are encouraged to enroll in clinical trials for adjuvant therapies. Information about ongoing clinical trials is available from the NCI website.

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Studies cited in this source section

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Preserved source evidence · Not medical advice