Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer

Phase 2

Recruiting

• Conditions: borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer

• Registration Number: JPRN-UMIN000015707
• Lead Sponsor: Tokyo Medical University Department of Gastrointestinal and Pediatric Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

(1).Prior radiotherapy or chemotherapy (2).Grade 2 or greater peripheral neuropathy (3).Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment (4).Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene (5).Moderate ascites (6).Intestinal pneumonitis or pulmonary fibrosis (7).Watery stool within 3 days before enrollment (8).Clinically significant heart disease (9).Active infection (HBS,HCV) (10).Uncontrolled diabetes mellitus (11).Serious complications (organ failure, or uncontrolled diabetes mellitus) (12).Serious complications (mental disorder, or central nervous system disorders) (13).Serious drug allergy (14).Active double cancer (15).Pregnancy (16).Treatment with atazanavir sulfate (17).Inappropriate for this study judged by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 resection rate

Secondary Outcome Measures

Name	Time	Method
resection rate, response rate, histological effect, 2-year survival, relapse free survival, feasibility, dose intensity, relative dose intensity, postoperative complication, safety