A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil Leucovorin and Liposomal Irinotecan in Older Patients with Treatment Na ve Metastatic Pancreatic Cancer (GIANT) ( s21-00700)

Brief description of study

The purpose of the study is to determine which of two treatment combinations, Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan, is more effective at lengthening the period of time that less fit patients over the age of 70 years with metastatic pancreatic cancer (mPCA) live. We hypothesize that pro-inflammatory biomarkers (IL-6 and CRP) and evaluation of sarcopenia through measurement of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) can serve as useful prognostic tools of overall survival and predictive tools for chemotherapy tolerance among older patients with metastatic pancreatic cancer. This study aims to obtain much needed data to guide oncologists as to the optimal management of patients over the age of 70 with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 and newly diagnosed metastatic pancreatic cancer.

Clinical Study Identifier: s21-00700
ClinicalTrials.gov Identifier: NCT04233866

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