NCT03109041已完成1 期
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
CivaTech Oncology2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
研究概览
简要总结
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
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
- •Subject signed informed consent
- •Age >/= 18 years
- •Biopsy confirmed adenocarcinoma pancreatic cancer
- •Patient capable of undergoing anesthesia
- •Patient is a surgical candidate
- •Patient selected to undergo pancreatic cancer resection
- •Patient will have known or suspected close/positive surgical margin
- •Confirmed diagnosis of resectable pancreatic adenocarcinoma
- •Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle
排除标准
- •Pregnant or breast feeding
- •Patient has metastatic disease
- •Patient has had prior radiation therapy to the region for separate cancer
- •Patient has had prior chemotherapy
- •Any other invasive cancer in the past 5 years, except basal cell skin
- •Recurrent or previously resected tumors
- •Alcoholism/Drug abuse
结局指标
主要结局
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
时间窗: 1.5 years
Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.
次要结局
未报告次要终点
研究者
研究点 (2)
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