Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of acute toxicity
研究概览
简要总结
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.
详细描述
CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.
Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject Signed Inform Consent
- •Subject plans to remain in the long-term care of his/her enrolling center/investigators.
- •Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
- •Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
- •Subject is able to undergo surgery
排除标准
- •Is unable or unwilling to comply with protocol requirements.
- •Is enrolled in another study/registry not approved by CivaTech Oncology.
- •Pregnancy, breast feeding
结局指标
主要结局
Rate of acute toxicity
时间窗: 90 days post implant
rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria
次要结局
- Dose to target and OAR(90 days)
- Local control rate(5 years)
- Reoperation rate(5 years)
- Complication rate(6 months)