Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer

By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

• Inclusion criteria
• Pathologically confirmed to be rectal adenocarcinoma.
• Distance < 10cm from the end of the tumor to the anal verge found on colonoscopy
• Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
• Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
• Patients with Karnofsky score greater ≥ 70
• WBC > 3.5 x 109/ml , PLT > 10 x 109/ml , TBIL<22.2 umol/l , BUN <7.14mmol/l , Cr<132umol/l or Ccr > 50ml/min (Evaluated using the Cockcroft-Gault formula: Creatinine clearance (male) = {(140 - age) x LBM (kg)} / {plasma creatinine (mg/dl) x 72} ; Creatinine clearance (female) = 0.85 x {(140 - age) x LBM(kg)}/ { plasma creatinine (mg/dl) x 72})
• Patients must sign the informed consent form
• Female subjects must be contraceptive during the trial
• Patients who did not receive any form of chemotherapy and radiotherapy
• No other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.)
• Age must be equal or more than 20 and must be equal or less than 70
• Exclusion criteria
• Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
• Previously received immuno-suppressive therapy
• Participation in interventional clinical trial over the past time
• Suffering from malignant colonic neoplasms simultaneously
• With peripheral neuropathy(above WHO I level)
• Affected cognitive abilities because of neurological or psychiatric abnormalities Including central nervous system metastasis
• Medical history of severe allergies or allergic constitution
• Severe pulmonary or heart disease history
• Female patients who are in pregnancy or lactation and refuse contraception
• Previously with other malignant tumors
• Exit criteria
• Occurrence of bleeding, obstruction, perforation and other complications
• Occurrence of distant metastasis during the period of neoadjuvant therapy
• Adverse reactions, not be tolerated and do not want to continue to receive treatment
• Patients voluntarily quit
• Capecitabine-related Grade 4 Hand-Foot Syndrome