There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
2-year disease-free survival
Proportion of patients without disease recurrence after 2 years
Time frame: 2 years
Disease-free survival
Median time point that 50% of study patients recur
Time frame: 4 years
Toxicities (Adverse events related with chemotherapy)
Adverse events related with chemotherapy
Time frame: 4 years
Overall survival
Median time point that 50% of study patients is alive
Time frame: 4 years
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