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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01531452
First received: February 6, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Stomach Neoplasms
Drug: Oxaliplatin
Drug: s1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: June 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531452

Contacts
Contact: Wen Zhang, MD 86-10-87788145
Contact: Lin Yang, MD 86-10-87788145 lyang69@sina.com.cn

Locations
China, Beijing
cancer hospital & Institute,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Wen Zhang, MD    86-10-87788145      
Contact: Lin Yang, MD    86-10-87788145    lyang69@sina.com.cn   
Principal Investigator: Lin Yang, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jinwan Wang, MD cancer hospital&institute,Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Lin Yang, MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01531452     History of Changes
Other Study ID Numbers: CH-GI-016
Study First Received: February 6, 2012
Last Updated: November 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Stomach Neoplasms
drug therapy
oxaliplatin
s1

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014