A randomized phase 2 study assessing the efficacy and safety of levofloxacin added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer(T-CORE2201)

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Levofloxacin treatment is added to the GEM/nabPT Xcombination therapy in patients with advanced pancreatic cancer. CONDITION: pancretic cancer PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: Overall survival,Response rate,Disease control rate,Overall response INCLUSION CRITERIA: 1) Histologically confirmed as adenocarcinoma of the pancreas. 2) Unresectable or advanced pancreatic cancer (Stage IV) or postoperative recurrent pancreatic cancer (No limitation on the period from the operation to the recurrence). 3) Patients who will receive GEM plus nabPT Xcombination therapy as the first line chemotherapy. 4) ECOG performance status 0 or 1. 5) Over 20 years old and under 80 years old. 6) Patients who have ability to understand the informed consent document for this clinical trial and who have signed to the informed consent document. 7) Fulfill the following hematological and biochemical data within 14 days before the registration. a) Leucocyte: >‐1500/mm3 b) Hemoglobin:>‐8.0 g/dl c) Platelets: 100,000/mm3 d) Total Bil: <‐2.0mg/dl e) Serum AST(GOT), serum ALT(GPT):<‐100 U/L f) Serum creatinine:<‐1.5 mg/dl g) One or more measurable lesions confirmed by CT or other imaging within 30 days before the registra
Epistemonikos ID: 29047988d8584fc1aa1afe317d706ad171de7e1a
First added on: Aug 26, 2024