Clinical trial NCT04002479: Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Unresectable Pancreatic Cancer
Metastatic Pancreatic Cancer
Pancreatic Adenocarcinoma
Keywords: pancreatic cancer
Unresectable Pancreatic Cancer
Metastatic Pancreatic Cancer
Pancreatic Adenocarcinoma
Pancreas Neoplasm
Alpha radiation
Pancreas Cancer
Pancreas Metastases
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.

Detailed description: This is a prospective, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer.

The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.

30 patients with advanced pancreatic cancer will be recruited by the investigational site.

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion.

Eligibility criteria: Inclusion Criteria:

* Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
* Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
* ECOG performance status ≤ 2
* Measurable lesion per RECIST (version 1.1) criteria
* Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
* ≥ 18 years of age
* Estimated life expectancy of at least 12 weeks
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
* Subjects are willing to sign an informed consent

Exclusion Criteria:

* Prior chemotherapy does not exclude the patient
* Prior abdominal radiation therapy
* Concomitant chemotherapy or immunotherapy
* Borderline resectable pancreatic cancer and medically fit for surgery
* Connective tissue disease (scleroderma, lupus)
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
* High probability of protocol non-compliance (in opinion of investigator)
* Patients not willing to sign an informed consent form
* Women who are pregnant or lactating

Primary outcomes:
measure: Feasibility - DaRT seed placement
timeFrame: Day 0 (Day of insertion)
measure: Safety - Adverse events
timeFrame: 3 months
measure: Safety - Adverse events
timeFrame: 3 to 24 months
Secondary outcomes:
measure: Efficiency - Short-term effect
timeFrame: 4-6 weeks after DaRT seeds insertion
measure: Tissue damage evaluation
timeFrame: Day -14 to 60 days after insertion
measure: Efficiency - Long-term effect
timeFrame: 2 years following DaRT seeds insertion
measure: Stent durability
timeFrame: Day of DaRT insertion up to 24 months.
measure: Change in quality of life: EORTC-QLQ-C30
timeFrame: Day -14 to 60 days after insertion
measure: Change in quality of life: QLQ-PAN26
timeFrame: Day -14 to 60 days after insertion
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Brachytherapy Service Centre Hospitalier de l'Université de Montreal
name: David Donath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Gastroenterology, Jewish General Hospital
name: Corey Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: