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

Johannes Gutenberg University (JGU)

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Cisplatin, Irinotecan, Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00675194

GC-ICE-2003

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)