drugset / Trial / NCT00677443
Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
Phase 3
Completed
344 enrolled
Samsung Medical Center
Asan Medical Center · collabChonnam National University Hospital · collabGachon University Gil Medical Center · collabNational Cancer Center, Korea · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabYonsei University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective : To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma. Secondary objectives : 1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. 2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-09
- Completion
- 2011-01
Publications
- Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial. BMC Cancer. 2014 Nov 26;14:883. doi: 10.1186/1471-2407-14-883.
- Hong YS, Park YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Jo SJ, Lee JW. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial. Lancet Oncol. 2012 Nov;13(11):1125-32. doi: 10.1016/S1470-2045(12)70363-7. Epub 2012 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | S-1 | Small molecule | 80 mg/m2 | — |