Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
This study will utilize ctDNA methylation detection to evaluate patients with high-risk T3N0 stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, regardless of sex;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of >3 months;
Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;
Positive ctDNA status at 1 month after surgery;
Disqualifiers
Receipt of neoadjuvant therapy prior to surgery;
Blood transfusion during surgery or within 2 weeks prior to surgery;
Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;
History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;
Trial design
Design model
Parallel
Treatments tested in this trial
Capecitabine
Drugcapecitabine for 6 months
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
DrugFOLFOX/CAPOX for 3 months; if ctDNA remains positive, switch to FOLFIRI.
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: Single-agent chemotherapy groupActive comparator 1 intervention
Group B: doublet chemotherapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient's 2-year Progression-Free Survival
Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria.
Time frame
2-year Progression-Free SurvivalSecondary outcomes
1
ctDNA-clearance Rate
ctDNA clearance rate is defined as the proportion of patients with detectable circulating tumor DNA (ctDNA) at baseline who achieve conversion to undetectable ctDNA at a predefined post-treatment time point, as assessed by the specified ctDNA assay.
Time frame
3 months after initiation of adjuvant therapy.Sponsors and contacts
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Source ClinicalTrials.gov