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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00675194
Enrollment
120
Registered
2008-05-08
Start date
2003-10-31
Completion date
2007-10-31
Last updated
2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy

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)

Interventions

DRUGCisplatin, Irinotecan, Capecitabine

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
safety
progression free survival
1 year survival
Quality of Life
Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026