Back to resultsA Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection
Primary Purpose
Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma
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
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine
Arm Description
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
Outcomes
Primary Outcome Measures
Primary objective: To investigate the proportion of patients who are recurrence-free for 2 years
Secondary Outcome Measures
Time to Recurrence (TTR) Recurrence Free Survival (RFS) QOL
Full Information
NCT ID
NCT01043172
First Posted
January 5, 2010
Last Updated
January 1, 2018
Sponsor
National Cancer Center, Korea
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01043172
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2009 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemcit
Intervention Description
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time to Recurrence (TTR) Recurrence Free Survival (RFS) QOL
Time Frame
Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Jin Lee, MD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection
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