A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Feasibility - DaRT seed placement
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility - DaRT seed placement
时间窗: Day 0 (Day of insertion)
Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
Safety - Adverse events
时间窗: 3 to 24 months
Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion
次要结局
- Change in quality of life: EORTC-QLQ-C30(Day -14 to 60 days after insertion)
- Tissue damage evaluation(Day -14 to 60 days after insertion)
- Efficiency - Long-term effect(2 years following DaRT seeds insertion)
- Stent durability(Day of DaRT insertion up to 24 months.)
- Efficiency - Short-term effect(4-6 weeks after DaRT seeds insertion)
- Change in quality of life: QLQ-PAN26(Day -14 to 60 days after insertion)