NCT04752930招募中不适用
Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Peritoneal Metastasis Free Survival (PMFS)
研究概览
简要总结
This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be a man or woman of at 18-75;
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
- •Patients with primary colorectal cancer proven by pathology；
- •Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
- •6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
- •Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
- •Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
- •Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.
排除标准
- •Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
- •ASA class Ⅳ to Ⅴ;
- •Patients who have other existence of distant metastasis outside the abdomen;
- •Patients with serious mental illness;
- •Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
- •Patients who cannot be followed up as scheduled;
- •Patients who participated in other clinical studies within 3 months prior to the trial;
- •Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
结局指标
主要结局
Peritoneal Metastasis Free Survival (PMFS)
时间窗: Through study completion, up to 3 years
The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
次要结局
- The ctDNA clearance rate before and after CRS+HIPEC treatment(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer(Through study completion, up to 3 years)
- The Overall Survival (OS) at 3 years after radical resection of colorectal cancer(Through study completion, up to 3 years)
- Positive Percent Agreement (PPA)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- Negative Percent Agreement (NPA)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- Peritoneal Cancer Index (PCI) Score(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- Detection Rate (DR)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- The time of peritoneal metastasis diagnosed after radical surgery(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
- Completeness of Cytoreduction (CC) Score(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
研究者
研究点 (1)
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