Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

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