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

Phase 2

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: Oxaliplatin; Drug: s1

• Registration Number: NCT01531452
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2012-11
• Study Completion: 2013-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	s1	oxaliplatin+s1
treatment	Oxaliplatin	oxaliplatin+s1

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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

Name	Time	Method
overall survival	2 years	From date of treatment was administered until the date of death from any cause,assessed every 3 months
number of participants with adverse events	2 years	assessed from treatment was administered until 1 months after withdrawing from study
Response Rate	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

Trial Locations

Locations (1)

cancer hospital & Institute,Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China