NCT03079427

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cholangiocarcinoma
• Biliary Tract Cancer
• Adjuvant Chemotherapy
• Capecitabine
• Gemcitabine
• Cisplatin

Interventions

Type	Name	Description
DRUG	Gemcitabine plus cisplatin	Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
DRUG	Capecitabine	Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks

Timeline

• Start date: 2017-05-15
• Primary completion: 2021-12-15
• Completion: 2022-11-15
• First posted: 2017-03-14
• Last updated: 2022-12-06

Locations

1 site across 1 country: South Korea