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This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to:
Full description
This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline:
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Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
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Interventional model
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30 participants in 2 patient groups
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Central trial contact
Liron Dimnik
Data sourced from clinicaltrials.gov
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