Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAlpha Tau Medical LTD.
About this trial
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 .
Eligibility criteria
Qualifiers
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
Disqualifiers
Concomitant immunotherapy within the past 4 weeks.
Patients with metastatic disease
Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.
Known hypersensitivity to any of the components of the treatment.
Trial design
Treatments tested in this trial
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
12CHU de Bordeaux Bordeaux France
CHU de Bordeaux Bordeaux France
Centre Jean PERRIN - Clermont-Ferrand Clermont-Ferrand France
Centre Georges François Leclerc Dijon Dijon France
Sponsors and collaborators
Alpha Tau Medical LTD.
Lead sponsor
Source ClinicalTrials.gov