Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2008
INTERVENTION: CPT‐11+CDDP arm: CPT‐11(60mg/m2) day1 CDDP(30mg/m2) day1 Every 2 weeks CPT‐11 arm: CPT‐11(150mg/m2) day1 Every 2 weeks CONDITION: S‐1 failure for Patients with Advanced and Recurrent Gastric Cancer PRIMARY OUTCOME: Progression‐free Survival SECONDARY OUTCOME: OS; TTF; Anti‐tumor Effect(Response rate); Adverse Event INCLUSION CRITERIA: 1.With pathologically proven gastric cancer 2. With at least one measurable lesion (RECIST) 3. S‐1 failure for Patients with Advanced and Recurrent Gastric Cancer 4. No prior immunotherapy and radiotherapy 5. 2 weeks or more pass from first line chemotherapy ends. 6. 4 weeks or more pass from Operation(Only the case who operated) 7. ECOG performance status<=2 8. Age 20 years old or more 9. Life expectancy estimated>=12 weeks 10. Sufficient organ functions 11.With written IC
Epistemonikos ID: 5e133a7f37eebb5c5dd051543f181e35c749f59a
First added on: Aug 21, 2024