Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 12
- 主要终点
- Safety of CivaSheet Radiation Treatement
研究概览
简要总结
Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
详细描述
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit 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. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.
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 inform consent
- •Age > 18 years
- •Not pregnant or breast feeding
- •Patient capable of undergoing anesthesia
- •Patient selected to undergo Whipple procedure or distal pancreatectomy
- •Patient does not have metastatic disease
- •Patients will have close margins
- •No prior radiation therapy to the region for separate cancer
- •Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
- •Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
- •Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
- •Gemcitabine + nb-paclitaxel
- •FOLFIRINOX
- •Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
- •up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
排除标准
- •Not surgical candidate
- •Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
- •An IRE candidate (IRE is Percutaneous irreversible electroporation)
- •Recurrent or previously resected tumors
- •Documented History of Alcoholism and or drug abuse
- •Participant in other clinical trials
结局指标
主要结局
Safety of CivaSheet Radiation Treatement
时间窗: 1 Year
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
次要结局
- Efficacy of CivaSheet Radiation Treatment(1 Year)
- Morbidity of patients following surgery and radiation(2 Year)
- Post Operative Radiation Dosimetry Calculation(1 Month)
- Length of Hospital Stay(1 Month)