Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion
Conditions
Interventions
None listed
Sponsors
Second Department of Surgery, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In the case where the primary lesion is confirmed to be pancreatic cancer by histology, cytology, or imaging examination, MDCT is used to diagnose the degree of progression, and NCCN guidelines (Version 1.2020) are applied to Borderline Resectable Pancreatic Carcinoma-Arterial (BRPC-A) 2. Initial treatment case 3. Performance status (ECOG) is 0 or 1 4. Cases where the age at the time of obtaining consent is 20 years or older and less than 80 years old 5. Cases where the functions of major organs meet the following criteria (latest value within 14 days before registration) White blood cells <=12,000/mm3 Neutrophil >=1,500/mm3 Hemoglobin value >=9.0g/dL Platelet >=100,000/mm3 Total bilirubin less than 2.0 mg/dL(3.0 mg/dL or less in obstructive jaundice cases) Serum creatinine<=1.5 mg/dL AST and ALT 2.5xbelow the facility upper limit 6. Cases in which consent for the participation in this study was obtained by the signature of the person before registration
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total algorithm treatment compliance rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKen-ichi Okada
Wakayama Medical University Second Department of Surgery
Outcome results
None listed