Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer: SOS
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
The urgent need for a new effective therapy with better safety profile for the metastatic
gastric cancer patients and promising results observed so far in the studies with S-1 plus
cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a
3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the
first-line treatment for AGC patients.
The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1
plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with
previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is
progression-free survival. This is an open label, randomized, multi-center,
non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.
Phase:
Phase 3
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Chonbuk National University Hospital Chonnam National University Hospital Gachon University Gil Medical Center Hallym University Medical Center Inje University Korea Cancer Center Hospital Kyungpook National University Kyungpook National University Hospital National Cancer Center, Korea Samsung Medical Center Seoul Veterans Hospital Ulsan University Hospital Yeungnam University College of Medicine