Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Distant metastasis from pancreas cancer.
Contraindication to having a magnetic resonance imaging (MRI) scan.
Prior abdominal radiation therapy.
Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.
Trial design
Treatments tested in this trial
- Stereotactic Ablative Body Radiation (SABR)
- Tumor Treating Fields (TTF)
Treatment groups
48 Participants
are divided into 1 treatment groupLocations
1Miami Cancer Institute at Baptist Health, Inc.33176, MiamiFlorida, United States
Sponsors and collaborators
Baptist Health South Florida
Lead sponsor
NovoCure Ltd.
Collaborator
Source ClinicalTrials.gov