500
Participants
Start Date
March 27, 2020
Primary Completion Date
February 1, 2026
Study Completion Date
February 1, 2026
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
Restaging
Restaging by pelvic magnetic resonance imaging (MRI)
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)
Surgery
Radical surgery (TME or more extended surgery)
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)
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
RECRUITING
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou
Yanhong Deng
OTHER