Spots Global Cancer Trial Database for A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

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Trial Identification

Brief Title: A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

Official Title: A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

Study ID: NCT01043172

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine

Study Description

Brief Summary: The investigators propose to evaluate efficacy and safety of gemcitabine in the adjuvant treatment of cholangiocarcinoma after potentially curative treatment with surgical resection.

Detailed Description: Cholangiocarcinoma is a highly fatal disease with poor prognosis. While Cholangiocarcinoma is generally rare in Western countries, it is more common in Korea, with an estimate of 3500 cases diagnosed annually. Currently, surgical resection remains the only potentially curative treatment, but many patients develop recurrence. Thus, effective postoperative adjuvant therapy is required to prolong survival in patients with cholangiocarcinoma. However, no standard postoperative treatment has been established yet. Among several different new anticancer drugs currently being investigated in the treatment of advanced biliary tract cancer, gemcitabine has generated particular interest. The nucleoside analogue gemcitabine has been reported to be active against advanced unresectable cholangiocarcinoma including cancer of the gallbladder, intrahepatic, and extrahepatic bile duct. So this is expected to be investigated in the adjuvant setting.