NCT00512681

A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

A Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Irinotecan, Oxaliplatin, TS-1	* S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning) * Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1 * Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-08-08
• Last updated: 2009-09-18

Locations

1 site across 1 country: South Korea