Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 990
- 试验地点
- 1
- 主要终点
- Recurrence-free survival at 3 years
研究概览
简要总结
The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:
- Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.
- Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.
325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •18 years old ≤ age < 75 years old.
- •Stage III (T1-4, N1-2, M0) colorectal cancer patients.
- •Patients who can undergo R0 resection.
- •ECOG score 0 ~
- •Expected survival ≥ 6 months.
- •No history of other malignant tumors.
- •Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.
排除标准
- •Patients who have received neoadjuvant chemotherapy.
- •Known high clinical risk of adjuvant chemotherapy.
- •Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).
- •Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).
- •Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.
- •There are any other circumstances that the researcher deems unsuitable for inclusion.
结局指标
主要结局
Recurrence-free survival at 3 years
时间窗: 3 years
次要结局
- Overall survival at 5 years(5 years)
- ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy(6 months)
- The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy(6 months)
研究者
Zhangfa Song
Vice director
Sir Run Run Shaw Hospital