Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 27, 2020

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2026

Conditions
Rectal Cancer
Interventions
DRUG

Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab

Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles and mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 2 cycles

PROCEDURE

Restaging

Restaging by pelvic magnetic resonance imaging (MRI)

RADIATION

Concomitant Chemoradiotherapy

Concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)

PROCEDURE

Surgery

Radical surgery (TME or more extended surgery)

RADIATION

Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)

Chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)

DRUG

Induction chemotherpay with FOLFOX

mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles

Trial Locations (1)

510655

RECRUITING

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

All Listed Sponsors
lead

Yanhong Deng

OTHER