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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043172
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : January 3, 2018
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Gemcitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection
Actual Study Start Date : July 20, 2009
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Gemcitabine
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
Drug: Gemcitabine
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
Other Name: Gemcit

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Time to Recurrence (TTR) Recurrence Free Survival (RFS) QOL [ Time Frame: Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects undergoing curative surgical resection for cholangiocarcinoma (including cancer of the gallbladder [except stage I], intrahepatic, and extrahepatic bile duct)
  • Histological confirmation is mandatory.
  • Age over 18 years old
  • Performance status (ECOG scale): 0-2
  • Adequate organ functions Hb ≥ 9.0 g/dl ANC: ≥ 1,500/mm3 PLT ≥ 100,000 /mm3 Liver function: Total Bilirubin ≤ 2.0 mg/dl AST / ALT / ALP ≤ 3× upper limit of normal Creatinine ≤ 1.5 ULN
  • Patients should sign a written informed consent before study entry.

Exclusion Criteria:

  • Tumor type other than adenocarcinoma
  • Stage I gallbladder cancer
  • Noncurative surgical resection including R2 resection
  • Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
  • Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
  • Prior radiotherapy
  • Major surgery within 4 weeks prior to study treatment except for surgical resection of cholangiocarcinoma
  • Serious illness or medical conditions, as follows; congestive heart failure (NYHA class III or IV) unstable angina or myocardial infarction within the past 6 months, significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block uncontrolled hypertension hepatic cirrhosis(≥ Child class B) interstitial pneumonia, pulmonary adenomatosis psychiatric disorder that may interfere with and/or protocol compliance unstable diabetes mellitus uncontrolled ascites or pleural effusion active infection
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
  • Pregnant or lactating woman
  • Women of child bearing potential not using a contraceptive method
  • Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  • Any patients judged by the investigator to be unfit to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043172

Korea, Republic of
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Dong-A Pharmaceutical Co., Ltd.
Principal Investigator: Woo Jin Lee, MD National Cancer Center, Korea

Responsible Party: Sang Myung Woo, MD, National Cancer Center, Korea Identifier: NCT01043172     History of Changes
Other Study ID Numbers: GATCO-1
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs