Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT06698458
Trial Phases:		Protocol IDs:	CTP-PANC-09 (primary) NCI-2025-07104
Eligibility:	18 - 120 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Alpha Tau Medical
NCI Full Details:	http://clinicaltrials.gov/show/NCT06698458

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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