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

This study is currently recruiting participants.

Verified February 2012 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: February 10, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2012

Last Updated Date

February 10, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01531452 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stomach Neoplasms

Intervention ^ICMJE

Drug: Oxaliplatin
130mg/m2 d1,repeated q21d

Other Name: eloxatin
Drug: s1
80mg/m2/d, d1-14,repeated q21d

Other Name: TS-1

Study Arm (s)

Experimental: treatment

oxaliplatin+s1

Interventions:

Drug: Oxaliplatin
Drug: s1

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01531452

Other Study ID Numbers ^ICMJE

CH-GI-016

Has Data Monitoring Committee

Responsible Party

Lin Yang, Chinese Academy of Medical Sciences

Study Sponsor ^ICMJE

Chinese Academy of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jinwan Wang, MD

cancer hospital&institute,Chinese Academy of Medical Sciences

Information Provided By

Chinese Academy of Medical Sciences

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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