Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer

UMIN ID: UMIN000000919

Registered date:01/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with gemcitabine-refractory advanced biliary tract cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S-1 was administered until disease progression. Dose of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days. BSA / daily dose <=1.25 m2 / 80 mg 1.25 m2 - 1.5 m2 / 100 mg >1.5 m2 / 120 mg

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: Toxicity, progression free survival, Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Regular use of fenitoin, warfarin or frucitocin 2) History of fluorinated pyrimidine use 3) Severe diarrhea 4) Severe mental disorder 5) Severe infection 6) Severe complication 7) Intestinal pneumonia or lung fibrosis 8) History of chest radiotherapy 9) Massive pleural or abdominal effusion 10) Symptomatic brain metastasis 11) History of other active malignancy 12) Pregnancy or the desire to preserve fecundity 13) Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare