A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
There is no regimen considered standard in advanced gastric cancer. The reported response
rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more
toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of
approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable
toxicity.
Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a
synergistic activity with LOHP in preclinical trials
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rates
Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
No
Ioannis Boukovinas, MD
Principal Investigator
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Greece: National Organization of Medicines
CT/04.18
NCT00447967
July 2004
September 2008
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