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Completed

NCT Number: NCT01531452

The Efficacy of Oxaliplatin Plus S-1 for Treatment of 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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

cancer hospital & Institute,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

130mg/m2 d1,repeated q21d

Other names: eloxatin

S1

Drug

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

Other names: TS-1

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 13, 2012
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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