Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
18 - 120 Years, Male and Female
CTP-PANC-09 (primary)
NCI-2025-07104
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.
Eligibility
- 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.
- ECOG Performance Status Scale 0 -2
- Life expectancy is more than 6 months
- WBC = 3500/µl, granulocyte = 1500/µl
- Platelet count =60,000/µl
- Creatinine =1.9 mg/dL
- AST and ALT = 2.5 X upper limit of normal (ULN)
- INR < 1.4 for patients not on Warfarin
- Age =18 years old
- Subjects are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.
- Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
Treatment Sites in Georgia
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