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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by National Cancer Center, Korea
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01043172
First received: January 5, 2010
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

The investigators propose to evaluate efficacy and safety of gemcitabine in the adjuvant treatment of cholangiocarcinoma after potentially curative treatment with surgical resection.


Condition Intervention Phase
Cholangiocarcinoma
Drug: Gemcitabine
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
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)
Arms Assigned Interventions
Experimental: Gemcitabine Drug: Gemcitabine
Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043172

Contacts
Contact: Sang Myung Woo, MD 82-31-920-1612 wsm@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Sang Myung Woo, MD    82-31-920-1612    wsm@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Woo Jin Lee, MD National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Sang Myung Woo, MD, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01043172     History of Changes
Other Study ID Numbers: GATCO-1
Study First Received: January 5, 2010
Last Updated: April 25, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014