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NCT05679674Recruiting

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

Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Source: ClinicalTrials.gov · Last updated 12 Jan 2026

Brief summary (registry, in English)

The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy 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 the tumor progresses or severe toxicity develops.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
27 Dec 2022
Start date
Sept 2023
Primary completion date
Jun 2027
Lead sponsor
Baptist Health South Florida
NCT number
NCT05679674

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From Sept 2023 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior abdominal radiation therapy.
  • History of any primary malignancy with the exception of:
    • Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • 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.

Other illness

  • Distant metastasis from pancreas cancer.
  • 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.
  • 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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].

Other

  • Contraindication to having a magnetic resonance imaging (MRI) scan.
  • 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.

Who the study is looking for

  • 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:
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Miami Cancer Institute at Baptist Health, Inc.
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.