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

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ClinicalTrials.gov Identifier: NCT00675194
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz

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


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Cisplatin, Irinotecan, Capecitabine Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2003
Actual Study Completion Date : October 2007





Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. safety
  2. progression free survival
  3. 1 year survival
  4. Quality of Life
  5. Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675194


Locations
Germany
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
Mainz, Germany, 55101
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Markus Moehler, MD Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier: NCT00675194     History of Changes
Other Study ID Numbers: GC-ICE-2003
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Johannes Gutenberg University Mainz:
cisplatin
capecitabine
gastric
irinotecan
metastatic
chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Cisplatin
Capecitabine
Camptothecin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors