NCT05201430View on ClinicalTrials.gov

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

June 30, 2024

Study Completion Date

July 31, 2027

Conditions
Rectal Cancer
Interventions
DRUG

FOLFOXIRI

irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400\~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)

DRUG

CapeOX

oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)

Trial Locations (1)

200032

RECRUITING

Department of Colorectal Surgery Fudan University Shanghai Caner Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER