Phase
Condition
Digestive System Neoplasms
Pancreatic Cancer
Treatment
Stereotactic Ablative Body Radiation (SABR)
Tumor Treating Fields (TTF)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced adenocarcinoma of thepancreas. Locally advanced pancreas cancer as per National Comprehensive CancerNetwork (NCCN) Guidelines.
Regional lymph node involvement is permitted if able to be treated with radiationtherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/orgemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distantprogression on restaging radiographic studies.
Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior tostudy enrollment.
Adequate normal organ and marrow function as defined below: i. Hemoglobin ≥8.0 g/dL that may be achieved with transfusion ii. Absoluteneutrophil count (ANC) ≥1500 per mm^3 iii. Platelet count ≥60,000 per mm^3 iv. Serumbilirubin ≤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 (hormonalor barrier method of birth control, abstinence) prior to study entry and for theduration of study participation. Should a participant become pregnant or suspectthey are pregnant while participating in this study, they must inform the treatingphysician immediately.
Able to operate the tumor treating field (NovoTTF-100L) system independently or withassistance.
All participants must sign written informed consent.
Exclusion
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:
Malignancy treated with curative intent and with no known active disease for atleast 3 years before enrollment on this study.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidenceof 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 irreversibletoxicity that is not reasonably expected to worsen by treatment on this study arepermitted 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 withevaluation of study treatment or interpretation of patient safety or study results.
Participants who are pregnant or breastfeeding. Patients with an electricalimplantable device in the torso. Examples of electrical implanted medical devicesinclude spinal cord stimulators, vagus nerve stimulators, pacemakers, anddefibrillators.
History of significant uncontrolled cardiovascular disease. Significant cardiacdisease includes second/third degree heart block; significant ischemic heartdisease; poorly controlled hypertension; congestive heart failure of the New YorkHeart Association (NYHA) Class II or worse.
History of arrhythmia that is symptomatic or requires treatment. Patients withatrial fibrillation or flutter controlled by medication are not excluded fromparticipation in the trial.
Known allergy to medical adhesives or conductive hydrogel [gel used onelectrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes].
Study Design
Connect with a study center
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United StatesActive - Recruiting
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