NCT04917289尚未招募3 期
Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Overall Survival
研究概览
简要总结
This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years;
- •Histologically proven colorectal cancer
- •All the lesion (s) has been R0 resected
- •Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests
- •More than 1 CTC has been detected (including 1)
- •Hematology tests suggest that they can tolerate chemotherapy
- •Written informed consent for participation in the trial
排除标准
- •Have any radiological evidence of recurrence
- •Other previous malignancy within 5 years
研究组 & 干预措施
Treatment Arm
Experimental
Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 year
Time from randomization to death
次要结局
- Disease free survival(3 year)
- Adverse event(1 year)
研究者
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