Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
Phase 2
Completed
- Conditions
- Gastric Cancer
- Registration Number
- NCT00675194
- Lead Sponsor
- 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
- Detailed Description
capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method safety progression free survival 1 year survival Quality of Life Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
Trial Locations
- Locations (1)
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
🇩🇪Mainz, Germany