A Study of NovoTTF-200T(P) with Chemotherapy for Resectable Pancreatic Cancer
This study is testing a combination of treatments for pancreatic adenocarcinoma (a type of pancreatic cancer) that can be removed by surgery. You would receive the drugs nab-paclitaxel and gemcitabine, along with a device called NovoTTF-200T(P). This device uses electric fields to target cancer cells. The study is looking to see how many people are alive after two years and how many can have their tumor successfully removed by surgery. To join, you must be at least 18 years old and have a good general health status. The current recruitment status is unclear.
- Study design
- This is a single-arm Phase II study, meaning everyone receives the same treatment. It plans to enroll 38 participants.
- What's involved
- You would receive three cycles of chemotherapy and wear the NovoTTF-200T(P) device for at least 18 hours daily. After surgery, you might receive three more cycles of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track how long participants live for up to two years, and the rate of tumor removal for up to four years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05624918
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentAshish ManneInvestigator-initiated
~38 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Nab paclitaxelGemcitabineNovoTTF-200T(P)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2 Year Overall Survival (OS)
Measured over 2 years
+1 more outcome measured
Conditions
NCT05624918
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ohio State University Comprehensive Cancer Center
Columbus, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ashish Manne, MD · PRINCIPAL_INVESTIGATOR · The Ohio State University Comprehensive Cancer Center- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Who to contact
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Eligibility criteria
Inclusion
Written informed consent and HIPAA authorization for release of personal health information.
Male or non-pregnant, non-lactating female age ≥ 18 years at the time of consent.
Karnofsky Performance Status (KPS) of ≥70% within 7 days prior to registration.
Histological or cytological evidence of pancreatic adenocarcinoma.
Patients must have resectable primary tumor per NCCN definitions version 2.2021 based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of PET/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as all of the following:
No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).
No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence.
No evidence of metastatic disease. NOTE: To minimize ineligible patients, an institutional checklist, identical to the one used by the central radiologist at the end of the study, will be mandated for completion by the enrolling site investigator or radiologist. The 6-point checklist will include visible pancreatic mass; measurable disease; absence of arterial interface; venous interface of less than or equal to 180°; patent portal-splenic confluence; and absence of metastatic disease, including lymphadenopathy outside the surgical basin.
Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.
Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer.
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to registration.
Hematological
Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
Hemoglobin (Hgb) ≥ 8.0 g/dL
Platelets ≥100,000/mm3
Renal
Calculated creatinine clearance ≥ 30 cc/min using the Cockcroft-Gault formula
Hepatic
Bilirubin ≤ 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≤ 3 × ULN
Alanine aminotransferase (ALT) ≤ 3 × ULN
Females of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to registration. See the protocol for definition of childbearing potential.
Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study, and for 6 months after the last dose of study drug(s). Males must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study, and for 3 months after the last dose of study drug(s). See also the protocol (contraception).
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.
Exclusion
Evidence of distant metastasis
Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.
History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial -Known allergy to medical adhesives or conductive hydrogel (gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes).
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease and treatment-free for two years.
Patient is unwilling or unable to comply with study procedures.
What this trial measures
- 2 Year Overall Survival (OS)2 years
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
- Rate of Resection4 years
Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.