Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,653
- 试验地点
- 42
- 主要终点
- Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease
研究概览
简要总结
This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.
详细描述
PRIMARY OBJECTIVES:
I. The principal objective of the RESIN registry is to evaluate response to therapy using objective response criteria such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of the Liver (EASL). The response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. Secondary criteria include overall survival, time to progression (TTP) and toxicity.
OUTLINE:
Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall oncologic management are added in the RESIN registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients receiving SIR-Spheres therapy to the liver for the first time.
- •Provision of written informed consent.
- •Age 18 and older.
排除标准
- •Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres).
- •Patients who have received Y90 treatment in the past and who are returning for another Y90 treatment are ineligible, even if new areas are being targeted.
- •Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.
结局指标
主要结局
Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease
时间窗: Up to 1 year after the first treatment
Response to treatment is the initial measure of treatment efficacy. This can be measured using objective criteria such as the modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of Liver Cancer (EASL) criteria depending on local policy and tumor type.
次要结局
- Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures(Up to 1 year after the first treatment)
- Overall Survival(2 years)
- Time to Progression(2 years)
研究者
Daniel B. Brown
Principal Investigator
Vanderbilt-Ingram Cancer Center