Phase I/II study of S-1, irinotecan plus oxaliplatin combination therapy (SOXIRI) for advanced pancreatic cancer(KANAPS 06 study)

Not Applicable

Recruiting

• Conditions: advanced pancreatic cancer

• Registration Number: JPRN-UMIN000014339
• Lead Sponsor: KANAPS(Kansai and Nara Pancreatobiliary Study group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

1) Grade 2 or greater peripheral neuropathy 2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 3) Moderate ascites 4)Intestinal pneumonitis or pulmonary fibrosis 5) Uncontrollable diarrhea 6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders) 7) Active double cancer 8) Pregnancy 9)Inappropriate for this study judged by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
phase I study: Safety,Frequency of DLTs phase II study: response rate

Secondary Outcome Measures

Name	Time	Method
progression-free survival, overall survival, and adverse events