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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceRadioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: DaRT SeedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety - Serious adverse events
Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria
Time frame
from Day 0 , up to 12 monthsSecondary outcomes
1
Efficacy - tumor response
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Objective tumor response rate according to RECIST 1.1
Time frame
Day 0 , up to 12 months2
Efficacy - overall survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Overall survival
Time frame
Day 0 , up to 12 months3
Efficacy - Progression-free survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to - Progression-free survival
Time frame
Day 0 , up to 12 months4
Efficacy - Percentage of R0/R1 resected patients
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Percentage of R0/R1 resected patients
Time frame
Day 0 , up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov