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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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
Hallym university medical center
Anyang, Gyunggi, South Korea
overall response rate
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Time frame: 1.5 years
progression free survival
The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause
Time frame: 1.5 years
overall survival
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
Time frame: 1.5 years
Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0
Time frame: 1.5 years
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