Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

This study is looking at whether a combination of stereotactic ablative body radiation (SABR) and Tumor Treating Fields (TTF) can slow tumor growth in people with locally advanced pancreas cancer. SABR is a type of radiation therapy, and TTF is a device that uses electric fields. You would receive SABR once a day for five days and use the TTF system for at least 18 hours daily until your cancer progresses. The study aims to see how long people live without their cancer growing (median progression-free survival) over two years. To join, you must have locally advanced pancreatic adenocarcinoma and meet certain health criteria. The study is currently unclear on its recruitment status and plans to enroll 48 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 48 participants.
What's involved
You would receive SABR once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until your abdominal disease progresses or severe side effects occur.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, median progression-free survival, is measured at 2 years.

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NCT05679674

Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Recruiting
NAAges 18+InterventionalTreatment
Baptist Health South Florida
~48 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:Stereotactic Ablative Body Radiation (SABR)Tumor Treating Fields (TTF)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median Progression Free Survival (PFS)
Measured over 2 years
Pancreas Cancer
Locally Advanced
Locally Advanced Pancreatic Adenocarcinoma
1 sites across 1 states
Florida1
  • Michael Chuong, M.D. · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute at Baptist Health, Inc.

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Eligibility criteria

Inclusion

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:
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

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:
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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].
  • Median Progression Free Survival (PFS)2 years

    PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first