NCT02527785

Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer

Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hallym University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.

Detailed description

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic gastric cancer is better than that compared to best supportive care. In general, combination chemotherapies are more efficient than monotherapy and so it is reasonable to give combination chemotherapy to patients with good performance status. Especially dual combination chemotherapy with fluoropyrimidine and platinum has shown the objective response rate of 25-48% in patients with newly diagnosed advanced metastatic gastric cancer and several studies about triple combination with oxaliplatin, irinotecan, and fluoropyrimidine have shown the response rate of 53\~75% but also higher rate of hematologic adverse events. So the investigators had conducted the phase I study of these three drugs with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

Conditions

• Stomach Neoplasm

Interventions

Type	Name	Description
DRUG	Oxaliplatin, Irinotecan, S-1(OIS)	Treatment will be delivered every 2 weeks 1. oxaliplatin 65 mg/m2 iv on day 1 2. irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day po on day 1-7

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-06-01
• Completion: 2017-04-01
• First posted: 2015-08-19
• Last updated: 2017-08-23

Locations

1 site across 1 country: South Korea