Patients with pancreatic cancer undergoing radical resection
Conditions
Interventions
After radical resection of pancreatic cancer, 5-FU hepatic arterial infusion and gemcitabine combination therapy are administered as adjuvant chemotherapy. The course of 28 days consists of 3 consecut
Sponsors
University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed as pancreatic cancer (pancreatic ductal carcinoma) by various imaging and pathological examinations and have undergone radical resection. Or, patients who have undergone hepatic resection for liver metastasis of pancreatic cancer and have undergone radical resection of the primary tumor. 2) No evidence of metastasis or recurrence by imaging diagnosis. 3) Patients must be at least 20 years of age. 4) Performance status (ECOG classification) of 0 or 1 5) No concurrent cancer of other organs 6) Preservation of major organ function (within 14 days prior to enrollment) 7) Have sufficient judgment to understand the study and provide written consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of liver metastases occurring 5 years postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, safety | — |
Countries
Japan
Contacts
Public ContactKazuto Shibuya
Faculty of Medicine, Academic Assembly, University of Toyama Department of Surgery and Science
Outcome results
None listed