Efficacy of Irinotecan and Capecitabine Versus(vs) Cispla... | NCT00675194

Studies
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer

NCT00675194

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

Cisplatin, Irinotecan, Capecitabine

Countries

Germany

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

May 2008

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

Oct 2003

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 2008Estimated

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

May 16, 2008

Last Update Posted Date

May 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer

Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety

Detailed Description

capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)

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

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cisplatin, Irinotecan, Capecitabine	Drug

Measure	Description	Time Frame
response rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gastric or gastric-oesophagal junction adenocarcinoma
unidimensional measurable disease
Karnofsky index >/=60%

Exclusion Criteria:

prior chemo- or radiotherapy
colorectal diseases
brain metastases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Moehler, MD	Johannes Gutenberg University Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik		Mainz		55101	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D009362	Neoplasm Metastasis

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
D002945	Cisplatin
D000077146	Irinotecan
D000069287	Capecitabine

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
safety
progression free survival
1 year survival