Back to resultsEfficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cisplatin, Irinotecan, Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy
Eligibility 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
Sites / Locations
- Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
safety
progression free survival
1 year survival
Quality of Life
Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
Full Information
NCT ID
NCT00675194
First Posted
May 6, 2008
Last Updated
May 16, 2008
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT00675194
Brief Title
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Irinotecan, Capecitabine
Primary Outcome Measure Information:
Title
response rate
Secondary Outcome Measure Information:
Title
safety
Title
progression free survival
Title
1 year survival
Title
Quality of Life
Title
Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Moehler, MD
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
City
Mainz
ZIP/Postal Code
55101
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
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