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

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Primary objective: To investigate the proportion of patients who are recurrence-free for 2 years

Secondary Outcome

 Time to Recurrence (TTR) Recurrence Free Survival (RFS) QOL

Condition

Cholangiocarcinoma

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitabine

Description:  Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

72

Start Date

July 20, 2009

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Woo Jin Lee, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT01043172

Organization ID

GATCO-1

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Center, Korea

Collaborators

 Dong-A Pharmaceutical Co., Ltd.

Study Sponsor

Woo Jin Lee, MD, Principal Investigator, National Cancer Center, Korea

Verification Date

January 2018