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CompletedNCT01531452Updated Dec 4, 2014

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

A Phase 2 interventional study of Oxaliplatin and s1 in Stomach Neoplasms, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stomach Neoplasms

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Keywords

  • Stomach Neoplasms
  • drug therapy
  • oxaliplatin
  • s1
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 43 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    treatment

    oxaliplatin+s1

    Drug: Oxaliplatin · Drug: s1

Interventions

  • DrugOxaliplatin

    130mg/m2 d1,repeated q21d

    Also known as: eloxatin

  • Drugs1

    80mg/m2/d, d1-14,repeated q21d

    Also known as: TS-1

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks

    Time frame: 2 years

Secondary outcomes

  1. Response Rate

    From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles

    Time frame: 2 years

  2. overall survival

    From date of treatment was administered until the date of death from any cause,assessed every 3 months

    Time frame: 2 years

  3. number of participants with adverse events

    assessed from treatment was administered until 1 months after withdrawing from study

    Time frame: 2 years

07

Study locations

1 site
  • cancer hospital & Institute,Chinese Academy of Medical Sciences
    Beijing, Beijing 100021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01531452
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Lin Yang (MD, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Feb 13, 2012
Start date
Jun 2011
Primary completion
Nov 2012
Completion
Jun 2013
Last update
Dec 4, 2014

Study contacts

Jinwan Wang, MD
principal investigator · cancer hospital&institute,Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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