A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer
- The urgent need for new effective therapy with better safety profile for metastatic
colorectal cancer patients and promising results observed so far in trials with S-1
combined with oxaliplatin in gastrointestinal cancer including colorectal cancer
strongly warrants the comparison of S-1 combined with oxaliplatin to capecitabine
combination with oxaliplatin acknowledged as a standard regimen in a first-line
treatment for advanced colorectal cancer patients.
- Recently, a Phase I study was completed, indicating recommended dose as S-1 100
mg/m2/day1-14 and oxaliplatin (130 mg/m2/day1), repeated every 3 weeks. However, in the
phase II study using the above recommended dose, delayed toxicities of thrombocytopenia
and anemia were observed. These delayed toxicities were also reported in a phase II
study using S-1 90 mg/m2/day plus oxaliplatin 130 mg/m2/day1 in advanced gastric
cancer. At 2007 GI ASCO, the interim data of S-1(80 mg/m2/day1-14) plus oxaliplatin
(130 mg/m2/day1) combination, repeated every 3 weeks, was presented, showing promising
antitumor activity with favourable safety profile. Among 18 patients, there were only
two patients with Grade 3 thrombocytopenia and one with Grade 3 neutropenia. Response
rate was 57.1 % and disease control rate was 92.9 %. Considering these results and
Japanese data which showed that enhanced efficacy was not observed with S-1 over 90
mg/m2/day and oxaliplatin combination, S-1 80 mg/m2/day 1-14 and oxaliplatin 130
mg/m2/D1, repeated every 3 weeks, will be tested in this study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.
9 months
Yes
Young Suk Park, M.D.,Ph.D.
Study Chair
Samsung Medical Center, Seoul, Korea
Korea: Food and Drug Administration
2008-03-012
NCT00677443
June 2008
January 2011
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