Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

Prior treatment

• Prior chemotherapy does not exclude the patient
• Prior abdominal radiation therapy
• Concomitant chemotherapy or immunotherapy
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids

Other illness

• Borderline resectable pancreatic cancer and medically fit for surgery
• Connective tissue disease (scleroderma, lupus)
• Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)

Other

• Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
• High probability of protocol non-compliance (in opinion of investigator)
• Patients not willing to sign an informed consent form
• Women who are pregnant or lactating

• Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
• Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
• ECOG performance status ≤ 2
• Measurable lesion per RECIST (version 1.1) criteria
• Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
• ≥ 18 years of age
• Estimated life expectancy of at least 12 weeks
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
• Subjects are willing to sign an informed consent