Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Patient's 2-year Progression-Free Survival
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
3-month doublet chemotherapy group
Patients in this group will get FOLFOX/CAPOX for 3 months
Intervention: CAPEOX regimen (Drug)
6-month doublet chemotherapy group
Patients assigned to the intervention group will receive adjuvant therapy with either FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
Intervention: CAPEOX regimen (Drug)
Outcomes
Primary Outcomes
Patient's 2-year Progression-Free Survival
Time Frame: 2 years
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.
Secondary Outcomes
- ctDNA-clearance Rate(6 months)
Investigators
Guoxiang Cai
Fudan University Shanghai Cancer Center
Fudan University