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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675194
First Posted: May 8, 2008
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johannes Gutenberg University Mainz
May 6, 2008
May 8, 2008
May 20, 2008
October 2003
Not Provided
response rate
Same as current
Complete list of historical versions of study NCT00675194 on ClinicalTrials.gov Archive Site
  • safety
  • progression free survival
  • 1 year survival
  • Quality of Life
  • Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
Same as current
Not Provided
Not Provided
 
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
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

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

capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
Drug: Cisplatin, Irinotecan, Capecitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • prior chemo- or radiotherapy
  • colorectal diseases
  • brain metastases
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00675194
GC-ICE-2003
Yes
Not Provided
Not Provided
Not Provided
Johannes Gutenberg University Mainz
Not Provided
Principal Investigator: Markus Moehler, MD Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
May 2008

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