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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01531452
First received: February 6, 2012
Last updated: December 3, 2014
Last verified: December 2014
History of Changes

February 6, 2012
December 3, 2014
June 2011
November 2012   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Same as current
Complete list of historical versions of study NCT01531452 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    assessed from treatment was administered until 1 months after withdrawing from study
Same as current
Not Provided
Not Provided
 
The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
  • Drug: Oxaliplatin
    130mg/m2 d1,repeated q21d
    Other Name: eloxatin
  • Drug: s1
    80mg/m2/d, d1-14,repeated q21d
    Other Name: TS-1
Experimental: treatment
oxaliplatin+s1
Interventions:
  • Drug: Oxaliplatin
  • Drug: s1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
June 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01531452
CH-GI-016
No
Not Provided
Not Provided
Lin Yang, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Jinwan Wang, MD cancer hospital&institute,Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP