Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility and translational analysis
研究概览
简要总结
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.
详细描述
In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.
SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.
The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.
The investigators expect to include up to 30 patients.
This is a purely observational translational study. Results will be analysed in relation to outcome data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
- •Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- •The Liver metastasis are not eligible for resection, RFA or SBRT
- •All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
- •All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
- •Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Age 18 years or older
- •Able to understand written information
- •Consent to samples for translational research
排除标准
- •Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
- •Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
- •Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
- •Lung shunt greater than 20% or > 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
- •Pregnancy
- •Symptomatic lung disease precluding SIRT at interventionist´s decision
- •Active uncontrolled infection
- •Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (>34 umol/l)
- •Current or previously evidence of ascites on CT-scan or physical examination
- •Tumour volume greater than 50% of liver volume
- •Conditions precluding translational samples
结局指标
主要结局
Feasibility and translational analysis
时间窗: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis
次要结局
- Progression Free Survival(3 years)
- Response Rate(6 months)
- Overall Survival(3 years)
研究者
Louise Bach Callesen
Principal Investigator
Aarhus University Hospital