Viewing Study NCT01946061



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Last Modification Date: 2024-10-26 @ 11:12 AM
Study NCT ID: NCT01946061
Status: TERMINATED
Last Update Posted: 2016-08-19
First Post: 2013-09-12

Brief Title: A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
Sponsor: Yonsei University
Organization: Yonsei University

Study Overview

Official Title: None
Status: TERMINATED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: This study was stopped because of difficulties of supplying the drug
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Patients with advanced gastric cancer have showed poor prognosis Only 81 of the patients could underwent curative surgery In those about 60 of patients would survive after 5 years from the surgery As a result role of chemotherapy has been increased In ACTS-GC trial S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients However subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV according to the AJCC 6th criteria gastric cancer In addition CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients Notwithstanding these trial optimal adjuvant regimen of advanced gastric cancer has not been established We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III according to the AJCC 7th criteria gastric cancer patients
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None