A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: Preoperative chemoradiotherapy with gemcitabine CONDITION: Patients with resectable pancreatic cancer and impaired renal function PRIMARY OUTCOME: Phase I: Safety ; Phase II: Pathological response 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
Epistemonikos ID: cfc876ca0cdd1a8ec10c2dcf823619cbe5902a77
First added on: Aug 23, 2024