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Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer
The study is a multi-center, open-label, randomized active-controlled study of patients with locally advanced pancreatic adenocarcinoma which is unresectable according to NCCN guidelines
Primary Objective: To compare the Overall Survival, from time of randomization until death, between patients receiving intra-arterial delivery of gemcitabine using the RenovoCath device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks in those patients with stable disease following induction therapy with IV gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Secondary Objectives: To compare in patients with locally advanced, unresectable pancreatic cancer treated with intra-arterial delivery of gemcitabine using the RenovoCath¿ device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks: 1. Primary Endpoint for treatment received and unresected analysis populations 2. Progression free survival assessed according to RECIST 1.1 for all analysis populations 3. Objective response rate and duration of response 4. Health Related Quality of Life assessed with the EORTC, PCQL-10 and S-PGI questionnaires 5. Degree of peripheral neuropathy 6. Frequency of neutropenia requiring the use of filgrastim or other medications for white blood cell stimulation 7. Tolerability and safety of the combination
Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Xeloda (capecitabine); capecitabine (); gemcitabine ()
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