Prospective observational study on preoperative algorithm treatment for Borderline Resectable Pancreatic Cancer with positive radiological arterial invasio

Not Applicable

Recruiting

• Conditions: Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion

• Registration Number: JPRN-UMIN000040792
• Lead Sponsor: Second Department of Surgery, Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-16
• Last Update Posted: 17 October 2023
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. Cases with a history of severe drug hypersensitivity or drug allergy 2. Cases with a history of malignant tumor (* If there is a recurrence-free period of 5 years or more, and endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, and basal cell carcinoma of the skin Or squamous cell carcinoma can be registered) 3. Cases with active infection 4. Patients with peripheral sensory neuropathy (Grade 2 or higher) 5. Cases with a history of interstitial pneumonia or pulmonary fibrosis 6. Patients with uncontrolled ascites or pleural effusion 7. Cases receiving atazanavir sulfate 8. Cases with uncontrolled diabetes 9. Uncontrollable congestive heart failure, angina, hypertension, arrhythmia 10. History of neurologically or psychologically significant disease, and cases with complications 11. Cases with diarrhea (including increased number of stools and watery stools) 12. Pregnant women, lactating women, and cases of possible pregnancy (will), or women and men who are not willing to contracept during the study period and for a certain period (180 days) after the last administration of the study drug 13. Patients with active hepatitis B 14. Regarding UGT1A1*6 and *28 gene polymorphisms, have either of them as homozygotes (UGT1A1*6/*6, UGT1A1*28/*28) or both as heterozygotes (UGT1A1*6/*28) Case

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total algorithm treatment compliance rate

Secondary Outcome Measures

Name	Time	Method
1. Total number of registered cases and overall survival of each treatment group 2. Total number of registered cases and recurrence-free survival time for each treatment group 3.1 year recurrence rate