A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Alpha Tau Medical LTD.
Summary
This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
Description
This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline and the chemotherapy choice at the physician's discretion: 1. Cohort 1: Locally advanced pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane 2. Cohort 2: Metastatic pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane Patients will begin mFOL…
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2). * Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion * Target lesion is technically amenable for Alpha DaRT sources implantation. * Measurable lesion per RECIST (version 1.1) criteria * Lesion size ≤ 5 cm in the longest diameter * Interstitial radiation indication validated by a multidisciplinary team. * E…
Interventions
- DeviceRadiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms
Locations (15)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- City of HopeGoodyear, Arizona
- Honor HealthScottsdale, Arizona
- Cedars-SinaiLos Angeles, California
- Advent Health Cancer InstituteOrlando, Florida
- Emory UniversityAtlanta, Georgia