Electric field therapy plus radiation: new hope for pancreas cancer?
NCT ID NCT05679674
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This clinical trial is testing whether adding a device that delivers low-intensity electric fields (Tumor Treating Fields) to targeted radiation therapy can slow tumor growth in people with locally advanced pancreas cancer. Participants will receive radiation for five days and use the device at home for at least 18 hours daily. The study aims to see if this combination improves how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) device
- What this could lead to
- If successful, this combination could slow tumor growth and improve progression-free survival for people with locally advanced pancreas cancer.
- What could go wrong
- This is a small, early-phase trial with only 48 participants. The treatment requires wearing the TTF device at least 18 hours daily, which may be burdensome, and side effects from radiation or the device are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas. Locally advanced pancreas cancer as per National Comprehensive Cancer Network (NCCN) Guidelines. * Regional lymph node involvement is permitted if able to be treated with radiation therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/or gemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies. * Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior to study enrollment. * Adequate normal organ and marrow function as defined below: i. Hemoglobin ≥8.0 g/dL that may be achieved with transfusion ii. Absolute neutrophil count (ANC) ≥1500 per mm\^3 iii. Platelet count ≥60,000 per mm\^3 iv. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) v. AST (SGOT)/ALT (SGPT) ≤3 x institutional ULN * People of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect they are pregnant while participating in this study, they must inform the treating physician immediately. * Able to operate the tumor treating field (NovoTTF-100L) system independently or with assistance. * All participants must sign written informed consent. Exclusion Criteria: * Distant metastasis from pancreas cancer. * Contraindication to having a magnetic resonance imaging (MRI) scan. * Prior abdominal radiation therapy. * History of any primary malignancy with the exception of: 1. Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease (i.e., cervical carcinoma in situ; superficial bladder cancer). * Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 \> grade 2) from previous anti-cancer therapy. Participants with irreversible toxicity that is not reasonably expected to worsen by treatment on this study are permitted to enroll on this study. * History of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis). * Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results. * Participants who are pregnant or breastfeeding. 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. * 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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Miami Cancer Institute at Baptist Health, Inc.
RECRUITINGMiami, Florida, 33176, United States
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