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

Gyeongsang National University Hospital

Status and phase: Terminated; Phase 2

Conditions: Locally Advanced Biliary Tract Cancer; Metastatic Biliary Tract Cancer

Treatments: Drug: Gemcitabine, Cisplatin; Drug: S-1, Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01096745

GNUHIRB-2010-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Gemcitabine/Cisplatin

Experimental group

Treatment:

Drug: Gemcitabine, Cisplatin

S-1/Cisplatin

Experimental group

Description:

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

Treatment:

Drug: S-1, Cisplatin