FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

738

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

April 30, 2021

Study Completion Date

April 1, 2026

Conditions
Colon Cancer
Interventions
DRUG

Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens

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) for 6 cycles followed by colectomy (3 to 5 weeks after) followed by mFOLFOX6 (6 cycles); 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) for 4 cycles followed by colectomy (3 to 5 weeks after) followed by CAPOX (4 cycles).

DRUG

Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens

Colectomy (maximum 4 weeks after randomization) followed by 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) for 12 cycles; Colectomy (maximum 4 weeks after randomization) followed by 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) for 8 cycles

Trial Locations (1)

510655

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER