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

NCT01043172 | Completed Phase 2

• 1 other identifier: GATCO-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up)

Secondary Outcomes (1)

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

  Jan 2010 - Jan 2014 (24 month enrollment, 24 month follow-up)

Study Arms (1)

Gemcitabine

EXPERIMENTAL

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

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

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

Also known as: Gemcit

Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Dong-A Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Woo Jin Lee, MD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: July 20, 2009
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)