ACTRN12626000906358进行中（未招募）不适用
Impact of combined chemotherapy and 32P implantation on clinical outcomes in patients with locally advanced pancreatic adenocarcinoma: a randomized controlled trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •Histologically or cytologically proven adenocarcinoma of the pancreas
- •Unresectable locally advanced pancreatic adenocarcinoma as per National Comprehensive Cancer Network (NCCN) guidelines (MDT review of imaging)
- •Considered fit to commence first-line standard FOLFIRINOX therapy
- •Able to provide informed consent
- •Life expectancy at least 3 months (as assessed by investigator)
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Willing and able to complete study procedures within the study timelines.
- •Provide signed Informed Consent.
- •Technically feasible – tumour must be within reach of the EUS probe for fine needle injection.
- •Standard first line chemotherapy with FOLFIRINOX will be commenced within 14 days post enrolment, with OncoSilTM implantation to occur during the 4th week from commencement of chemotherapy.
- •Provide signed informed consent
排除标准
- •Evidence of metastatic disease
- •More than one pancreatic tumour lesion
- •Any prior radiotherapy or chemotherapy for pancreatic cancer
- •Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit, whichever is longer
- •Pregnant or lactating
- •Known history of hypersensitivity to silicon or phosphorus
- •In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
- •a) Where previous EUS-FNA was considered technically too difficult to perform due to anatomy/vessels/varices
- •b) Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas
- •c) Presence (or significant risk) of varices near to the target tumour.
- •(Note: The feasibility of implantation of the target tumour and assessment of risk can be conducted at any time between screening and the implantation date. A study participant should be considered for withdrawal prior to and including at the time of OncoSil™ treatment, if any of the above risk features become apparent following participant screening)
- •Patients who do not consent to chemotherapy
研究者
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