Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)

Phase 2

• Conditions: biliary tract neoplasm

• Registration Number: JPRN-UMIN000001685
• Lead Sponsor: Japan Clinical Oncology Group(JCOG)

Brief Summary

See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-04
• Study Completion: 2011-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Watery diarrhea 7) Active bacterial or fungous infection 8) Severe complication 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival (1-year survival)

Secondary Outcome Measures

Name	Time	Method
progression-free survival, response rate, adverse events, severe adverse events