A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
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.
Detailed 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 mFOLFIRINOX or Gemcitabine/Abraxane treatment depending on their assigned cohort and will undergo DaRT placement during the first 4 cycles of chemotherapy.
Arms & 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
Outcome measures
Primary
Safety -Serious adverse events
The primary endpoint is the incidence of treatment-related Serious Adverse Events (SAEs) graded according to CTCAE v5.0
Time frame: From Day 0 ,up to 24 months.
Secondary
Complete or pain response
Time frame: 30 days and 2 months post-procedure
Percentage of locally advanced that became surgically resectable
Time frame: 6 and 24 months
Eligibility criteria
Study locations (13)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
City of Hope
Goodyear, Arizona, 85338
Honor Health
Scottsdale, Arizona, 85258
Cedars-Sinai
Los Angeles, California, 90048
Advent Health Cancer Institute
Orlando, Florida, 32804
Emory University
Atlanta, Georgia, 30308
Bassett Healthcare Network
Cooperstown, New York, 13326
NYU Langone Health
New York, New York, 10016
Lenox hill Hospital
New York, New York, 10075
Montefiore Medical Center
The Bronx, New York, 10467
Texas Oncology
Houston, Texas, 75251
Baylor College of Medicine
Houston, Texas, 77054
University Cancer and Diagnostic
Houston, Texas, 77089