Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers

PHASE3RecruitingINTERVENTIONAL
Enrollment

840

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2026

Conditions
Colon Cancer Stage IIColon Cancer Stage III
Interventions
DRUG

neoadjuvant chemotherapyI

mFOLFOXIRI (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV Irinotecan 150 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 48h every 14 days) for 6 cycles followed by colectomy (3 to 6 weeks after) . If PD was observed after 3 cycles, direct colectomy was performed.

PROCEDURE

Colectomy

Radical colectomy

DRUG

adjuvant chemotherapy

mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) . CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) . Oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days. The plan and cycles are determined according to the surgical pathology and physical conditions.

Trial Locations (1)

510060

RECRUITING

651 Dongfeng Road East, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER