Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Inclusion criteria

• 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.

Exclusion criteria

• End-stage cachexia patients;
• Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
• Metastatic carcinoma;
• Incomplete or complete intestinal obstruction;
• Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
• Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
• Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;
• History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
• Serious organic disease including but not limited to heart, kidney, brain, and lung.