A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection
The investigators propose to evaluate efficacy and safety of gemcitabine in the adjuvant treatment of cholangiocarcinoma after potentially curative treatment with surgical resection.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection|
- Primary objective: To investigate the proportion of patients who are recurrence-free for 2 years [ Time Frame: Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up) ] [ Designated as safety issue: Yes ]
- Time to Recurrence (TTR) Recurrence Free Survival (RFS) QOL [ Time Frame: Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up) ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
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.
|Contact: Sang Myung Woo, MDfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Contact: Sang Myung Woo, MD 82-31-920-1612 email@example.com|
|Principal Investigator:||Woo Jin Lee, MD||National Cancer Center, Korea|