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

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-10-31

Brief Summary

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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

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

Conditions

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Gastric Cancer

Keywords

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cisplatin capecitabine gastric irinotecan metastatic chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cisplatin, Irinotecan, Capecitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* prior chemo- or radiotherapy
* colorectal diseases
* brain metastases

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Markus Moehler, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

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Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GC-ICE-2003

Identifier Type: -

Identifier Source: org_study_id