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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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


Inclusion Criteria:



- gastric or gastric-oesophagal junction adenocarcinoma

- unidimensional measurable disease

- Karnofsky index >/=60%

Exclusion Criteria:

- prior chemo- or radiotherapy

- colorectal diseases

- brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

Markus Moehler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg University Mainz

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GC-ICE-2003

NCT ID:

NCT00675194

Start Date:

October 2003

Completion Date:

October 2007

Related Keywords:

  • Gastric Cancer
  • cisplatin
  • capecitabine
  • gastric
  • irinotecan
  • metastatic
  • chemotherapy
  • Stomach Neoplasms

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