Actively Recruiting
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Led by Baptist Health South Florida · Updated on 2026-01-12
48
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
N
NovoCure Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas as per NCCN Guidelines
- Regional lymph node involvement allowed if treatable 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 chemotherapy without distant progression
- Carbohydrate antigen 19-9 (CA 19-9) level 64500 U/mL prior to enrollment
- Adequate organ and marrow function including hemoglobin 658.0 g/dL, ANC 651500/mm3, platelets 6060,000/mm3, bilirubin 641.5 x institutional ULN, AST/ALT 643 x institutional ULN
- Use of adequate contraception for people of childbearing potential during study participation
- Ability to operate the NovoTTF-100L tumor treating field system independently or with assistance
- Signed written informed consent
You will not qualify if you...
- Presence of distant metastasis from pancreas cancer
- Contraindication to magnetic resonance imaging (MRI) scan
- Prior abdominal radiation therapy
- History of primary malignancy except for treated cancers with no active disease for at least 3 years or certain treated non-melanoma skin or carcinoma in situ cancers
- Unresolved toxicity greater than grade 2 from previous anti-cancer therapy unless irreversible and not expected to worsen
- History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Any condition interfering with treatment evaluation or safety interpretation
- Pregnancy or breastfeeding
- Presence of electrical implantable devices in the torso (e.g., pacemakers, defibrillators)
- Significant uncontrolled cardiovascular disease including advanced heart block, ischemic heart disease, poorly controlled hypertension, or congestive heart failure NYHA Class II or worse
- Symptomatic or treated arrhythmia except controlled atrial fibrillation or flutter
- Known allergy to medical adhesives or conductive hydrogel used in device electrodes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
M
Michael Chuong, M.D.
CONTACT
C
Carla Salazar
CONTACT
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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