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.
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: 1. Locally advanced 2. Metastatic. Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
NOT_YET_RECRUITINGCity of Hope
Goodyear, Arizona, United States
NOT_YET_RECRUITINGHonor Health
Scottsdale, Arizona, United States
RECRUITINGCedars-Sinai
Los Angeles, California, United States
NOT_YET_RECRUITINGAdvent Health Cancer Institute
Orlando, Florida, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGBassett Healthcare Network
Cooperstown, New York, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGLenox hill Hospital
New York, New York, United States
NOT_YET_RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITING...and 5 more locations
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.
Complete or pain response
Complete or partial pain response at 30 days and 2 months postprocedure as compared to baseline based on average pain scale using BPI-SF (Brief Pain Inventory - Short Form) used to evaluate the severity of a patient's pain, 0-no pain, 1 to 3- mild pain, 4 to 7- moderate pain, 8 to 10- severe pain .
Time frame: 30 days and 2 months post-procedure
Percentage of locally advanced that became surgically resectable
For cohort 1 only: Percentage of locally advanced patients with tumors that became surgically resectable after DaRT treatment
Time frame: 6 and 24 months
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