Patients with resectable pancreatic cancer and impaired renal function
Conditions
Interventions
Preoperative chemoradiotherapy with gemcitabine
Sponsors
Clinical Study Group of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven pancreatic adenocarcinoma (2) Age between 20 and 80 years (3) ECOG performance status of 0 or 1 (4) Creatinine clearance <60 ml/min (excluding dialysis patients) (5) Surgically resectable (6) Life Expectancy must be >=6 months (7) Adequate hematologic, hepatic and respiratory function (8) Interval of at least 4 weeks between prior treatment and start of present study (9) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Unresectable pancreatic cancer (2) Dialysis patients (3)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible (4) Active infections (excluding viral hepatitis) (5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (6) Presence of pleural effusion or ascites requiring drainage (7) Presence of metastasis in central nervous system (8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years) (9) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period. (10) Severe mental disorder (11) Severe drug hypersensitivity (12) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Safety Phase II: Pathological response | — |
Countries
Japan
Contacts
Public ContactHidetoshi Eguchi
Osaka University Gastroenterological Surgery
Outcome results
None listed