Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.

Phase 2

• Conditions: Advanced biliary tract cancer with carcinomatous ascites

• Registration Number: JPRN-UMIN000007520
• Lead Sponsor: The University of Tokyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with synchronous or metachronous concomitant malignancies 2) Patients with uncontrolled diabetes mellitus 3) Patients with uncontrolled hypertension 4) Patients with renal failure undergoing hemodialysis 5) Patients with prior myocardial infarction or unstable angina within 6 months 6) Patients with liver cirrhosis 7) Patients with intestinal pneumonia, pulmonary fibrosis, and severe pulmonary emphysema 8) Pregnant or lactating female and patients who is considering pregnancy 9) Patients with contraindication for S-1 or paclitaxel 10) Inappropriate patients for entry on this study in the judgement of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival Anti-tumor effect(Response rate, Disease control rate) Effect for carcinomatous ascites One-year survival rate Drug administration compliance(Drug intensity, Drug feasibility)