Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The primary efficacy end point was recurrence- free survival at 12 months.
研究概览
简要总结
This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).
详细描述
The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
- •medically able to receive chemotherapy.
排除标准
- •evidence of infective disease before enrollment ,
- •a history of another primary cancer within the previous 3 years,
- •the presence of synchronous primary colorectal cancer.
研究组 & 干预措施
RAS unmutated CTCs HER positive
干预措施: panitumumab (EGFR inhibitors) (Drug)
RAS unmutated CTCs HER negative
干预措施: panitumumab (EGFR inhibitors) (Drug)
CTCs
干预措施: panitumumab (EGFR inhibitors) (Drug)
结局指标
主要结局
The primary efficacy end point was recurrence- free survival at 12 months.
时间窗: 12 months
次要结局
未报告次要终点