A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer

Phase 2

• Conditions: Biliary tract cancer

• Registration Number: JPRN-UMIN000020801
• Lead Sponsor: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-01
• Study Completion: 2021-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1) synchronous or metachronous double cancer, excluding carcinoma in situ or intramucosal carcinoma cured by local treatment 2) allergy for contrast medium for CT and MRI 3) brain metastasis 4) blood transfusion, blood products, or hematopoietic growth factor preparations such as G-CSF within 7 days before enrollment 5) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28 6) apparent coelomic fluid (pleural effusion, ascites, or pericardial fluid) 7) serious concomitant diseases 8) abnormal findings in ECG 9) intestinal pneumonia 10) poorly controlled diabetes 11) diarrhea including watery stools within 3 days before enrollment 12) grade 2 or higher peripheral sensory neuropathy 13) active infection other than HBV or HCV 14) serious allergy 15) history of severe drug allergy 16) pregnant or lactating woman 17) disqualified for trial by principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified