Shandong New Time (age) Pharmaceutical Co., LTD
Conditions
Interventions
test group:S-1 plus oxaliplatin
control group:fluorouracil and folinic acid plus oxaliplatin
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients should sign a written informed consent before study entry; 2. Age over 18 years old; 3. Histologically documented metastatic colorectal adenocarcinoma; 4. No less than one measurable lesion(>=10 mm as assessed by spiral CT scan or >=20 mm as assessed by common CT scan); 5. No Prior systemic therapy and finish adjuvant treatment more than 12 months; 6. Performance status (ECOG scale): 0-2; 7. Life expectancy >=12 weeks.
Exclusion criteria
Exclusion criteria: 1. Adjuvant treatment for non-metastatic (M0) disease has been completed within 12 months prior to initiation of study treatment; 2. Prior radiotherapy was administered to target lesions selected for this study; 3. Operable metastatic disease; 4. Patients with unrelieved toxicity of grade 2 or greater severity during anticancer treatment before, except baldness; 5. Combination with target therapy, such as anti-VEGF mAb or anti-EGFR mAb; 6. Presence of CNS metastasis; 7. Insufficiency of bone marrow function defined as the following: An absolute neutrophil count (ANC) =9 g/dL; 8. Serum bilirubin >=1.5 times upper limit of reference ranges (ULRR); 9. AST and ALT >=2.5 times ULRR (> 5 times ULRR if liver metastases present); 10. Serum creatinine> 1.5 times ULRR or creatinine clearance <=50 mL/min according to Cockcroft-Gault; 11. Patients with uncontrolled systemic disease; 12. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery; 13. Pregnant or lactating woman, or child-bearing period woman with pregnancy tests positive before receiving treatment; 14. Patients with known sensitivity to oxaliplatin, 5-fluorouracil, folinic aci, s-1; 15. With other anticancer therapy (including LHRH agonist, anticancer traditional Chinese drug, immunotherapy),except steroid hormones); 16. Other prior malignancy in 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix; 17. Patients with history of gastrointestinal tract disturbance, which may significantly influence the absorption of S-1, including the ability to swallow the whole tablet; 18. Patients with peripheral neuropathy of grade 2 or greater severity; 19. Patients with deisoxypyridoxine hydrochloride deficiency; 20. Patients who have been selected or randomized in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DTR;Liver metastasis resection rate;Economic Evaluation;safety; | — |
Countries
China
Contacts
Public ContactFeng Bi
Outcome results
None listed