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

National Cancer Center (NCC)

Status and phase

Completed

Phase 2

Conditions

Cholangiocarcinoma

Treatments

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01043172

GATCO-1

Details and patient eligibility

About

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

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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