Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
Recruiting · NCT06167967 · Interventional (participants receive a specific treatment) · Lead sponsor: Sir Run Run Shaw Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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: 1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients. 2. 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.
Who can take part
Inclusion criteria
- 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 \~ 2.
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Sir Run Run Shao hospital - Hanzhou, Zhejiang, China