A multicenter, randomized, open label, phase III trial to evaluate the efficacy and safety of the combination of S-1, oxaliplatin and irinotecan in comparison to the combination of S-1 and cisplatin as first-line treatment in patients with metastatic or relapsed gastric cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003166
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 286
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 < 1.5 mg/dL or creatinine clearance > 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method overall survival;objectiveresponse rate;Quality of life;safety;disease control rate