Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)

Not Applicable

Recruiting

• Conditions: Biliary tract cancer

• Registration Number: JPRN-UMIN000029421
• Lead Sponsor: Department of Surgery, Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1)with history of TS-1 administration 2)with interstitial pneumonia or pulmonary fibrosis within 28 days before accrual 3)with diarrhea 4)with clinically important infection 5)blood infusion within 14 days before accrual 6)sever complication(heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, ileus, uncontrollable diabetes mellitus etc) 7)more than moderate degree of ascitic fluid and pleural effusion 8)has active carcinoma except carcinoma in situ 9)administered flucytosine, Phenytoin, Warfarin potassium 10) pregnant women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 11) known sever drug allergies 12) sever mental disorder 13) doctor's decision not to be registered to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified