A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
- Conditions
- Patients with pancreatic cancer undergoing radical resection
- Registration Number
- JPRN-UMIN000053630
- Lead Sponsor
- niversity of Toyama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 75
Not provided
1) Active multiple carcinoma (synchronous multiple carcinoma and heterochronic multiple carcinoma with a disease-free interval of 5 years or less) However, active multiple carcinoma does not include intraepithelial carcinoma or intramucosal carcinoma equivalent lesions that are considered curable with local treatment. 2) Have clear infection or inflammation requiring systemic treatment. 3) Fever of 38.0 degrees or higher at the time of enrollment 4) Allergy or contraindication to 5-FU or gemcitabine 5) History of serious drug hypersensitivity or drug allergy 6) Allergy to contrast media that precludes contrast studies 7) Serious cardiac disease or history of cardiac disease 8) Serious underlying disease (uncontrolled diabetes mellitus, renal failure, cirrhosis, etc.) 9) Has ascites or pleural effusion that is difficult to control 10) Active gastrointestinal bleeding requiring repeated blood transfusions 11) Diarrhea (more than 4 times a day or watery stools) 12) Uncontrolled cancer pain 13) Pulmonary fibrosis or interstitial pneumonia evident on imaging or clinical findings 14) Pregnant or lactating woman or possible (intended) pregnancy 15) Psychiatric illness or psychiatric symptoms that would preclude participation in the study 16) Unable to give consent to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of liver metastases occurring 5 years postoperatively
- Secondary Outcome Measures
Name Time Method Overall survival, progression-free survival, safety