A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer
Trial Parameters
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Eligibility Criteria
Inclusion Criteria * Histologically and/or cytologically proven locally advanced or metastatic pancreatic adenocarcinoma * Patients must have i) received at least one line of chemotherapy OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery or the patient does not wish to go through surgery * Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician * Interstitial radiation indication validated by a multidisciplinary team * Measurable lesion per RECIST (version 1.1) criteria * Lesion size ≤ 5 cm in the longest diameter * Age ≥18 years old * ECOG Performance Status Scale ≤ 2 * Life expectancy is more than 6 months * WBC ≥ 3500/µl, granulocyte ≥ 1500/µl * Platelet count ≥60,000/µl * Calculated or measured creatinine clearance ≥ 60cc/min. Calculated or measured creatinine clearance can be≥ 40cc/min given stability of creatinine levels over the pas