Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,104
- 试验地点
- 48
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate, in terms of overall survival, the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone. Initially expected target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients, because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90% and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104 patients enrolled.
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 diagnosed with metastatic colorectal cancer with biopsy positive for adenocarcinoma.
- •ECOG PS0-
- •Who have not received prior chemotherapy treatment for metastatic disease.
- •Measurable or evaluable disease.
- •No previous surgery for metastatic disease. Surgery for metastasis allowed after inclusion in the study aftercare at the discretion of investigadors.
- •Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)
排除标准
- •Patients older than 70 years with frailty criteria.
研究组 & 干预措施
Active comparator: Chemotherapy
Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
干预措施: Chemotherapy (Drug)
Experimental: Chemotherapy plus mAb
Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
干预措施: Chemotherapy plus monoclonal antibody (Biological)
结局指标
主要结局
Overall survival
时间窗: From July 2018 (LPI), 24 months
From date of inclusion until the date of death from any cause.
次要结局
- Evaluate Sadananda cellular phenotype classification(From August 2014, up to 36 months)
- Validate prognostic score GEMCAD(From August 2014, up to 36 months)
- To compare GERCOR and Köhne classification with GEMCAD classification(From August 2014, up to 36 months)
- Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy(From August 2014, up to 36 months)