Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAPEOX regimen, CAPEOX regimen.
- Who it may be relevant to
- Registry conditions: ctDNA, Colorectal Cancer, Chemotherapy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.
Detailed description
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.
Interventions
- Drug CAPEOX regimen
CAPEOX regimen for 3 months - Drug CAPEOX regimen
6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months
Primary outcome measures
- Patient's 2-year Progression-Free Survival [Time frame: 2 years]
Secondary outcome measures (1)
- ctDNA-clearance Rate [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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;
- Expected survival of >12 months;
- Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative/guardian), indicating that the subject understands the study objectives and required procedures and agrees to participate.
Exclusion criteria
- 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;
- Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;
- Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function;
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07562503 · 2410-Exp102 · U25A20115