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
Qualifiers
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
Treatments tested in this trial
- Capecitabine
- FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Treatment groups
340 Participants
are divided into 2 treatment groupsLocations
1Fudan University Shanghai Cancer Center Shanghai China
Sponsors and collaborators
Fudan University
Lead sponsor
Source ClinicalTrials.gov