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

Phase 2
20 Years
Not Enrolling
Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Hyuk-Chan Kwon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dong-A University Hospital


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

July 2010

Completion Date:

September 2013

Related Keywords:

  • Metastatic Biliary Tract Cancer
  • Locally Advanced Biliary Tract Cancer
  • Gemcitabine
  • Cisplatin
  • S-1
  • bile duct cancer
  • Biliary Tract Neoplasms