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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Oxaliplatin Drug: s1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
Study Start Date : June 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment
oxaliplatin+s1
 Drug: Oxaliplatin
130mg/m2 d1,repeated q21d
Other Name: eloxatin

Drug: s1
80mg/m2/d, d1-14,repeated q21d
Other Name: TS-1


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. overall survival [ Time Frame: 2 years ]
    From date of treatment was administered until the date of death from any cause,assessed every 3 months

  3. number of participants with adverse events [ Time Frame: 2 years ]
    assessed from treatment was administered until 1 months after withdrawing from study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531452


Locations
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China, Beijing
cancer hospital & Institute,Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Jinwan Wang, MD cancer hospital&institute,Chinese Academy of Medical Sciences
More Information
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Responsible Party: Lin Yang, MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01531452    
Other Study ID Numbers: CH-GI-016
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Lin Yang, Chinese Academy of Medical Sciences:
Stomach Neoplasms
drug therapy
oxaliplatin
s1
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents