A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .
• Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma
• Target lesion is technically amenable for Alpha DaRT sources implantation.
• Measurable lesion per RECIST (version 1.1) criteria
• Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX
• Lesion size ≤ 5 cm in the longest diameter
• Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure
• Patients have received 8 - 12 cycles of mFOLFIRINOX
• ECOG Performance Status Scale 0 - 1
• Life expectancy is more than 6 months
• WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
• Platelet count ≥60,000/µl
• Creatinine ≤1.9 mg/dL
• AST and ALT ≤ 2.5 X upper limit of normal (ULN)
• INR \< 1.4 for patients not on Warfarin
• Age ≥18 years old
• Subjects are willing and able to sign an informed consent form
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy
• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.