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A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
July 1, 2024
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2028
Last Updated
July 31, 2025
38
ESTIMATED participants
Nab paclitaxel
DRUG
Gemcitabine
DRUG
NovoTTF-200T(P)
DEVICE
Lead Sponsor
Ashish Manne
Collaborators
NCT07409272
NCT04605913
Data Source & Attribution
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