NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000919

Registered date:01/12/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with gemcitabine-refractory advanced biliary tract cancer
Date of first enrollment2007/09/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
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 Outcomeresponse rate
Secondary OutcomeToxicity, progression free survival, Overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1) Biliary tract cancer histologically confirmed as adenocarcinoma 2) Progression during GEM-based first-line chemotherapy 3) Oral intake is possible 4) Measurable or assessable metastatic lesion(s) 5) Age of more than 20 years 6) ECOG performance status (PS) of 0 to 2 7) Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen 8) Adequate organ function 9) Written informed consent
Exclude criteria1) 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

Contact

public contact
Name Eiichiro Suzuki
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba Japan
Telephone 04-7133-1111
E-mail eisuzuki@east.ncc.go.jp
Affiliation National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
scientific contact
Name Junji Furuse
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba Japan
Telephone 04-7133-1111
E-mail jfuruse@east.ncc.go.jp
Affiliation National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division