The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
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ClinicalTrials.gov Identifier: NCT01531452 |
Recruitment Status
:
Completed
First Posted
: February 13, 2012
Last Update Posted
: December 4, 2014
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Sponsor:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
Tracking Information | ||||
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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 |
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
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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 |
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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 |
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Condition ICMJE | Stomach Neoplasms | |||
Intervention ICMJE |
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Study Arms | Experimental: treatment
oxaliplatin+s1
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
43 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |