SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients

This is an interventional treatment trial for Colorectal Cancer Stage III focused on measuring Tegafur，gimeracil and oteracil potassium, Capecitabine, compliance, quality of life, adverse reaction, disease free survival, overall survival Read More

Inclusion Criteria:

• Signed written consent form;
• age ≥18 years old;
• randomization within 2-8 weeks after surgery;
• Performance status of the US Eastern Cancer Cooperative Group (ECOG) score 0-1;
• pathologically diagnosed as stage III colon or rectal adenocarcinoma patient;
• Accept effective contraceptive measures;
• postmenopausal women; pregnancy test negative 72 hours before randomization;
• R0 resection.

Exclusion Criteria:

• primary tumor metastasis (including tumor cells in the ascites or the occurrence of peritoneal metastasis);
• presence of clinical relevant cardiovascular disease;
• presence of disease history of central nervous system, or evidence confirmed subjects suffering from central nervous system diseases;
• presence of grade 3 (or over grade 3) peripheral neuropathy, according to the common adverse event evaluation criteria (CTCAE) v. 3.0;
• post-operative radiotherapy must be implemented in patients according to researchers' assessment,;
• presence of any unresolved toxicity left from previous anti-cancer treatment left > grade 2 according to CTCAE, except hair loss;
• simultaneous use of targeted therapeutic drugs, such as anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-epidermal growth factor receptor (EGFR) monoclonal antibody;
• brain metastases or meningeal metastases;
• Insufficiency of bone marrow reserve capacity, the presence of neutrophils absolute count ≤ 1.5 × 109 / L or platelet count ≤ 75 × 109 / L, or the need for regular blood transfusion in order to maintain hemoglobin ≥ 9g / dL;
• Serum bilirubin ≥1.5 × upper limit of reference range (ULRR);
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × ULRR;
• serum creatinine ≥ 1.5 × ULRR or Cockcroft-Gault formula calculated creatinine clearance ≤ 50ml / min;
• Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes, massive active bleeding);
• undergo a major surgery within 14 days prior to entering the study, or surgical incision that has not yet healed completely;
• women who are pregnant or breastfeeding, or women who are positive for pregnancy before the trial;
• subjects known to be allergic to oxaliplatin, capecitabine, S-1 or any ingredient of these products;
• combination of other anti-cancer treatment (including gonadotropin-releasing hormone agonists, anti-cancer Chinese medicine, immunotherapy), except for steroid hormones;
• In the past 5 years there are other malignant tumor history, except curative treatment of skin basal cell carcinoma and / or cervical cancer in situ;
• have a significant history of gastrointestinal damage, the researchers judge may significantly affect the absorption of S-1, including dysphagia;
• subjects known suffering dihydropyrimidine dehydrogenase (DPD) deficiency.