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

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Feb 26, 2018

Keywords

ClinConnect Summary

In patients with pathological stage III colorectal cancer, capecitabine combined with oxaliplatin, as routinely prescribed for adjuvant chemotherapy prolongs the patient's 5-year disease-free survival and overall survival (about 3.4% -4.2%) and is therefore recommended by the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) and other international guidelines. Accumulating evidence has shown that a majority of chemotherapy-related side effects were caused by capecitabine, especially in certain patients with hand-foot syndrome lasting a long time. Teg...

Gender

ALL

Eligibility criteria

• 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.