Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.
• MRI evaluated of T3-4 or N+ rectal cancer;
• Pathologically diagnosed of rectal adenocarcinoma;
• 18 to 75 years old;
• Distance from lower margin of tumor to anus \<15 cm and suitable for anus-preserving resection;
• Tumor amenable to radical resection;
• Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;
• Laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 100×10\^9 /L, Hemoglobin ≥ 80 g/L, Serum bilirubin ≤ 24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60 U/L, Serum creatinine ≤ 110 umol/L;
• Be capable to receive a surgery;
• No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
• No previous systemic chemotherapy for treating colorectal cancer;
• Life expectancy of more than 3 months;
• No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
• Be willing and able to understand the study and to provide written informed consent.