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NCT00675194 Clinical Trial

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

Gastric Cancer Clinical Trial

Official title:
A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00675194
Other study ID # GC-ICE-2003
Secondary ID
Status Completed
Phase Phase 2
First received May 6, 2008
Last updated May 16, 2008
Start date October 2003
Est. completion date October 2007

Study information
Verified date May 2008
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- gastric or gastric-oesophagal junction adenocarcinoma

- unidimensional measurable disease

- Karnofsky index >/=60%

Exclusion Criteria:

- prior chemo- or radiotherapy

- colorectal diseases

- brain metastases

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Cisplatin, Irinotecan, Capecitabine

Locations
Country Name City State
Germany Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik Mainz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary response rate
Secondary safety
Secondary progression free survival
Secondary 1 year survival
Secondary Quality of Life
Secondary Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
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