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

NCT ID: NCT01531452

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

Detailed Description

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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.

Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

oxaliplatin+s1

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

130mg/m2 d1,repeated q21d

s1

Intervention Type DRUG

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

Interventions

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Oxaliplatin

130mg/m2 d1,repeated q21d

Intervention Type DRUG

s1

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

Intervention Type DRUG

Other Intervention Names

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eloxatin TS-1

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Lin Yang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinwan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

cancer hospital&institute,Chinese Academy of Medical Sciences

Locations

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cancer hospital & Institute,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CH-GI-016

Identifier Type: -

Identifier Source: org_study_id