Actively Recruiting
A Phase II Study of Peri-Operative NovoTTF-200T(P) with Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Led by Ashish Manne · Updated on 2026-04-08
38
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Ashish Manne
Lead Sponsor
N
NovoCure GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the combination of NovoTTF-200T(P) 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-200T(P) 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.
CONDITIONS
Brief Title
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Male or non-pregnant, non-lactating female aged 18 years or older
- Karnofsky Performance Status of 70% or higher within 7 days before registration
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Resectable primary tumor per NCCN guidelines verified by contrast-enhanced CT or MRI
- Measurable disease according to RECIST v1.1 within 28 days prior to registration
- No prior surgery, radiation, chemotherapy, targeted therapy, or investigational treatment for pancreatic cancer
- Adequate organ function based on blood counts, kidney and liver tests within 28 days prior to registration
- Negative pregnancy test for females of childbearing potential within 3 days prior to registration
- Willingness to use effective contraception during study and specified period after last dose
- Ability to understand and comply with study procedures
- HIV-positive patients on stable therapy with undetectable viral load within 6 months
- Patients with hepatitis B or C must have undetectable viral load or be cured
You will not qualify if you...
- Evidence of distant metastasis
- Presence of electrical implantable devices in the torso (e.g., pacemakers, defibrillators)
- Significant uncontrolled cardiovascular disease or symptomatic arrhythmias
- Known allergy to medical adhesives or conductive hydrogel
- Pregnant or breastfeeding
- Prior or concurrent malignancy that may interfere with study assessments
- Any severe uncontrolled medical condition that increases safety risks or affects protocol compliance
- History of malignancy unless disease and treatment-free for at least two years (except certain skin or cervical cancers)
- Unwillingness or inability to comply with study procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 cycles of 28 days each
Participants receive 3 cycles of chemotherapy with Nab-paclitaxel and Gemcitabine combined with continuous use of the NovoTTF-200T(P) device.
Visits on days 1, 8, and 15 of each 28-day cycle for chemotherapy infusion; NovoTTF-200T(P) worn >18 hours per day continuously during treatment
Duration - Up to 8 weeks after initial treatment
Participants with stable disease or better after initial treatment undergo pancreatectomy within 8 weeks.
1 surgical procedure visit plus associated hospital stay
Duration - 3 cycles of 28 days each within 8 weeks post-surgery
Participants who have surgery with R0 or R1 resection receive an additional 3 cycles of chemotherapy and NovoTTF-200T(P) device use.
Visits on days 1, 8, and 15 of each 28-day cycle for chemotherapy infusion; NovoTTF-200T(P) worn >18 hours per day continuously during treatment
Duration - Up to 4 years
Participants are monitored for survival and disease outcomes over several years after treatment completion.
Periodic visits for assessment of survival, disease status, and adverse events
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Ashish Manne, MD
A
Ahran Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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