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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531452
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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