Actively Recruiting
Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
Led by Sir Run Run Shaw Hospital · Updated on 2024-05-17
990
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and less than 75 years old
- Stage III colorectal cancer (T1-4, N1-2, M0)
- Able to undergo complete tumor removal (R0 resection)
- ECOG performance status score of 0 to 2
- Expected survival of at least 6 months
- No history of other malignant tumors
- Willing to participate and provide informed consent (with witness if unable to read)
You will not qualify if you...
- Received chemotherapy before surgery (neoadjuvant chemotherapy)
- Known high clinical risk for adjuvant chemotherapy
- Clear contraindications to adjuvant chemotherapy due to health, comorbidities, second cancer, or age
- Unable to undergo chemotherapy due to travel, compliance, or other reasons
- Vulnerable populations such as mental illness, cognitive impairment, critical illness, minors, or pregnant women
- Any other conditions deemed unsuitable by the researcher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
B
Bingjun Bai, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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