Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2028

Conditions
High-risk Stage II Colorectal CancerStage III Colorectal CancerCirculating Tumor DNA Methylation
Interventions
DRUG

mFOLFIRINOX adjuvant chemotherapy

mFOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycles

DRUG

mFOLFOX6/XELOX adjuvant chemotherapy

mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 12 cycles or XELOX (oxaliplatin 130mg/m2, ivgtt, Q3w; capecitabine 1000mg/m2, p.o, Q3w) for 8 cycles

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER