None listed
Conditions
Interventions
Drug :
Irinotecan (135 mg/m2) IV for 90 min, followed by oxaliplatin (85 mg/m2) IV for 2 h on day 1. S-1 (40 mg/m2) given orally twice daily on days 1–7. Treatment is repeated every 2 weeks.
Cispla
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma. 2) Measurable or evaluable lesion according to RECIST criteria v1.1 3) Chemotherapy naïve patients (except for adjuvant or neoadjuvant chemotherapy, which was completed more than 6 months before randomization). 4) Age 19 or more 5) Eastern Cooperative Oncology Group performance status 0-1 6) Adequate organ functions – Adequate bone marrow function: absolute neutrophil count >1,500/µL, Hb 9.0 g/dL, and platelets>100,000/µL – Adequate renal function: creatinine 60 ml/min – Adequate hepatic function: serum bilirubin = 2.5 x UNL (upper normal limit), AST and ALT = 2.5 x UNL (= 5 x ULN in the presence of liver metastasis) 7) Estimated life expectancy of more than 3 months 8) Given written informed consent prior to study-specific screening procedures
Exclusion criteria
Exclusion criteria: 1) Other tumor types than adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma 2) HER2-positive tumors 3) Participated in other clinical trial within 4 weeks before randomization 4) Prior radiotherapy on target lesion within 4 weeks before randomization 5) Bowel obstruction or gastrointestinal bleeding precluding S-1 PO administration 6) Surgery within 4 weeks before randomization 7) Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 12 months. 8) Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease 9) Significant neurologic or psychiatric disorders including CNS metastasis 10) History of another malignancy within the last two years except cured basal cell carcinoma f skin and cured carcinoma in–situ of uterine cervix. 11) Peripheral neuropathy with functional impairment 12) Hypersensitivity to drugs used in this clinical study 13) Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. 14) Genetic disorders such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 15) Severe diarrhea more than 3 grade or chronic inflammatory bowel disease 16) diagnosed with interstitial pneumonia or pulmonary fibrosis 17) Chicken pox patients 18) Patients with hearing loss 19) Patients who are considered difficult to participate in the clinical study by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objectiveresponse rate;Quality of life;safety;disease control rate | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeong Su Kim
Hallym University Medical Center-Kangnam
Outcome results
None listed