Clinical trial NCT01096745: Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
Official title: Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Biliary Tract Cancer
Locally Advanced Biliary Tract Cancer
Keywords: Gemcitabine
Cisplatin
S-1
bile duct cancer
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Dong-A University
name: Chung-Ang University
First posted: 2010-03-31
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

Detailed description: Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Eligibility criteria: Inclusion Criteria:

* Age : older than 20
* Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
* Histologically confirmed adenocarcinoma of the biliary tract
* Metastatic or unresectable biliary cancer
* No prior chemotherapy for biliary cancer
* A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
* Adequate bone marrow, liver, renal function

Exclusion Criteria:

* A patient with no measurable disease
* A patient who received previous palliative chemotherapy for biliary cancer
* A patient who received adjuvant chemotherapy for biliary cancer within 1year
* A patient with previous active or passive immunotherapy.
* A pregnant or lactating patient

Primary outcomes:
measure: Time to progression
timeFrame: From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan
Secondary outcomes:
measure: Response rate Overall survival Safety profile
timeFrame: Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang University Hospital
state: Gyeongsang Namdo
Study officials:
affiliation: Dong-A University Hospital
name: Hyuk-Chan Kwon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang University Hospital
name: Jung Hun Kang, M.D.
role: STUDY_DIRECTOR
References: