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OpenTrials
Completed

NCT Number: NCT00675194

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

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

Completed

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik

Mainz, 55101, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cisplatin, Irinotecan, Capecitabine

Drug

Primary outcomes

  1. response rate

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2007
First posted
May 8, 2008
Registry last updated
May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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