None listed
Conditions
Interventions
S-1, 25 mg / m2 will be administered orally (PO) twice a day (BID) from Day 1 to Day 21, followed by a recovery period from Day 22 to Day 28. This regime should be repeated every 4 weeks.
S-1 will be administered on an empty stomach, that is, one hour before or one hour after a meal, with a glass of water (approximately 100 mL) and before the infusion of cisplatin on Day 1. Cisplatin, 75 mg/m2, intravenously (IV) will be administered. as an infusion of 1 to 3 hours on Day 1. This regime sho
5-FU, 1000 mg / m2 / 24 hours will be administered intravenously by continuous infusion (CI, Continuous Infusion) for 120 hours from Day 1 to 5. This regime should be repeated every 4 weeks. The CI of 5-FU will be subsequent to the infusion of cisplatin on Day 1.
Cisplatin 100 mg / m2 IV will be administered as an infusion of 1 to 3 hours on Day 1. This regime should be repeated every 4 weeks for a maximum of 6 cycles.
Sponsors
TAIHO PHARMA USA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. You have granted written consent. 2. Has metastatic or locally advanced gastric cancer (Stage IV) histologically confirmed, not resectable. 3. Has a measurable or measurable but not measurable disease. 4. No previous palliative chemotherapy is allowed. 5. You can take medications orally. 6. You are> 18 years old. 7. At least 3 weeks of previous major surgery occurred. 8. At least 4 weeks of previous radiotherapy were passed. 9. Has an activity status 0 to 1 according to ECOG. 10. It has an adequate organic function. 11. Is willing and able to comply with scheduled visits, treatment plans, laboratory analyzes and other study procedures
Exclusion criteria
Exclusion criteria: 1. Patients who have had treatment with any of the following: a) Any prior palliative chemotherapy or any prior therapy for malignancy. b) Coadjuvant or neoadjuvant therapy within the last 12 months. c = Concurrent treatment with an anticancer agent in research. d = Previous cisplatin as neo-adjuvant chemotherapy and / or adjuvant with cumulative doses> 300 mg / m2. e)> 25% of irradiated medullary bone. f) Concurrent treatment with an agent under investigation or within 30 days of randomization. g) Current enrollment in another clinical study. 2. Has a serious illness. 3. Patient is receiving concomitant treatment with drugs that interact with S-1. 4. Patient is receiving concomitant treatment with drugs that interact with 5-FU. 5. Patient is receiving concomitant treatment with drugs that interact with cisplatin. 6. Patient is is a woman and is pregnant or breastfeeding. 7. Has a known hypersensitivity to 5-FU or cisplatin. 8. Patients with reproductive potential who refuse to use adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:General survival: time from randomization to patient death Timepoints:At the time of the event | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Global response index (ORR): Computed tomography and chest x-ray. Duration of the response (DR). Time to tumor response (TTR): Clinical evaluation. Survival without progression (PFS): Until the moment of progression or death of the patient. Time to treatment failure (TTF): Moment in which disease progression occurs, discontinuation or death from any cause. Clinical benefit: ECOG activity status and weight loss. Measure:Global response index (ORR). Duration of the response (DR). Time to the tumor response (TTR). Survival without progression (PFS). Time to tumor progression (TTP). Time to treatment failure (TTF). Clinical benefit Timepoints:Global response index (ORR). Duration of the response (DR). Time to the tumor response (TTR). Clinical benefit: Clinical evaluation at the beginning of each cycle. Survival without progression (PFS). Time to treatment failure (TTF): Moment in which disease progression occurs, discontinuation or death from any cause. | — |
Countries
Czech Republic, Estonia, Germany, Hungary, Italy, Peru, Spain, United Kindgdom
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed