Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

Phase 2

Terminated

• Conditions: Metastatic Biliary Tract Cancer; Locally Advanced Biliary Tract Cancer
• Interventions: Drug: S-1, Cisplatin; Drug: Gemcitabine, Cisplatin

• Registration Number: NCT01096745
• Lead Sponsor: Gyeongsang National University Hospital

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.

Study Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Study Start: 2010-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23
• Primary Completion: 2013-03
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-1/Cisplatin	S-1, Cisplatin	D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Gemcitabine/Cisplatin	Gemcitabine, Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Time to progression	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 Outcome Measures

Name	Time	Method
Response rate Overall survival Safety profile	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

Trial Locations

Locations (1)

Gyeongsang University Hospital; 🇰🇷 Jinju, Gyeongsang Namdo, Korea, Republic of