Phase II Study of NovoTTF-200TP with Gemcitabine and Nab-Paclitaxel Before and After Surgery for Treatable Pancreatic Adenocarcinoma

What this Trial Is About

This research aims to evaluate the combination of NovoTTF-200TP device therapy with gemcitabine and nab-paclitaxel chemotherapy in adults with resectable pancreatic adenocarcinoma. It is a single-arm phase II trial focusing on patients who have tumors suitable for surgical removal based on specific imaging criteria, with the goal of improving treatment outcomes before and after surgery. Participants will receive three 28-day cycles of nab-paclitaxel and gemcitabine administered intravenously on days 1, 8, and 15, alongside continuous daily use of the NovoTTF-200TP device for at least 18 hours per day during these cycles. After these initial treatments, patients will undergo imaging to assess disease status. Those with stable or improved disease will have surgery to remove the tumor within eight weeks. If surgery achieves clear or near-clear margins, an additional three cycles of the same chemotherapy and device treatment will follow within eight weeks post-surgery. Patients who do not undergo surgery due to progression or treatment complications continue in the study evaluations. Throughout the study, participants will be monitored with scans such as CT or MRI, laboratory tests, and assessments of treatment side effects and response. Researchers will measure outcomes including overall survival over two years, rate of tumor resection, response rates, disease-free survival after surgery, patterns of cancer recurrence, and compliance with the device use. Safety will be assessed through tracking adverse events at multiple time points. The total study duration includes treatment, surgery, follow-up, and long-term monitoring up to four years for some measures.

A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma