Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Difference from baseline in the number of free mutant DNA in blood
研究概览
简要总结
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.
The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female, age superior to 18 years.
- •Histologically confirmed metastatic colorectal adenocarcinoma.
- •Measurable disease according to the RECIST 1.1 guideline
- •ECOG performance status <
- •Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
- •No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy
- •Signed and dated informed consent document.
排除标准
- •Medical history of cancer within 5 years
- •Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
- •Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
研究组 & 干预措施
Patients Treated for Metastatic Colorectal cancer
Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer
干预措施: Blood sampling for free mutant DNA analysis (Procedure)
结局指标
主要结局
Difference from baseline in the number of free mutant DNA in blood
时间窗: 5 weeks
Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)
次要结局
- Difference from baseline in the number of free mutant DNA in blood(3 weeks)
- Evaluation of response based on the RECIST 1.1 guideline(3 Months)