The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

Tracking Information
First Submitted Date ICMJE	February 6, 2012
First Posted Date ICMJE	February 13, 2012
Last Update Posted Date	December 4, 2014
Study Start Date ICMJE	June 2011
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 10, 2012)	Progression Free Survival [ Time Frame: 2 years ]; from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01531452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 10, 2012)	Response Rate [ Time Frame: 2 years ]From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles; overall survival [ Time Frame: 2 years ]From date of treatment was administered until the date of death from any cause,assessed every 3 months; number of participants with adverse events [ Time Frame: 2 years ]assessed from treatment was administered until 1 months after withdrawing from study
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
Official Title ICMJE	a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
Brief Summary	The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
Detailed Description	There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Stomach Neoplasms
Intervention ICMJE	Drug: Oxaliplatin 130mg/m2 d1,repeated q21d Other Name: eloxatin; Drug: s1 80mg/m2/d, d1-14,repeated q21d Other Name: TS-1
Study Arms	Experimental: treatment; oxaliplatin+s1; Interventions: Drug: Oxaliplatin; Drug: s1
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 3, 2014)	43
Original Estimated Enrollment ICMJE; (submitted: February 10, 2012)	44
Actual Study Completion Date	June 2013
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma; Measurable lesion and/or non-measurable lesion defined by RECIST; ECOG performance status ≦ 1; Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3; Creatine ≦ upper normal limit (UNL); Total bilirubin ≦ 1.5 X UNL; AST, ALT and ALP ≦ 2.5 x UNL Subjects must be able to take orally; No prior chemotherapy; Life expectancy estimated than 3 months; Written informed consent Exclusion Criteria: Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant Known brain metastases History of hypersensitivity to fluoropyrimidines, oxaliplatin; Active double cancer; Treatment with any investigational product during the last 4 weeks prior to study entry; Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0; Any previous chemotherapy or radiotherapy for AGC
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01531452
Other Study ID Numbers ICMJE	CH-GI-016
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lin Yang, Chinese Academy of Medical Sciences
Study Sponsor ICMJE	Chinese Academy of Medical Sciences
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Jinwan Wang, MD cancer hospital&institute,Chinese Academy of Medical Sciences
PRS Account	Chinese Academy of Medical Sciences
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP