The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gas... | NCT01531452

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

NCT01531452

Sponsor

Chinese Academy of Medical Sciences

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

43Actual

Phase

Phase 2

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin
s1

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Jun 2013Actual

First Submitted Date

Feb 6, 2012

First Submission Date that Met QC Criteria

Feb 10, 2012

First Posted Date

Feb 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental	oxaliplatin+s1	Drug: Oxaliplatin Drug: s1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	130mg/m2 d1,repeated q21d	treatment	eloxatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2 years

Secondary Outcomes

Measure	Description	Time Frame
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	2 years
overall survival	From date of treatment was administered until the date of death from any cause,assessed every 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinwan Wang, MD	cancer hospital&institute,Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
cancer hospital & Institute,Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100021	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
C079198	S 1 (combination)
C103828	titanium silicide

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided