unresectable or recurrent gastric cancer
Conditions
Interventions
S-1 is administered orally at the dose of 40mg/m2 twice a day for 28 days, followed by 14 days rest.
Cisplatin is administered intravenously twice a week for 4 weeks, followed by 2 weeks rest.
The
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer 2) With measurable or assessable legion(s) 3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible. 4) Adequate bone marrow, hepatic and renal function (1)Hb >= 9.0 g/dl (2)WBC 4,000 - 12,000/mm3 (3)neutrophils >= 2,000/mm3 (4)platelets >= 100,000/ mm3 (5)T-Bil <= 1.5mg/dl (6)GOT, GPT <= 2.5 times of normal upper limits (7)Al-p <= 2 times of normal upper limits (8)BUN <= normal upper limits (9)Cr<= normal upper limits (10)CCr >= 50ml/min 5) ECOG performance status (PS) 0 to 1 6) Life expectancy longer than 3 months 7) Oral intake is possible 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) severe complication(s) 2) symptomatic brain metastases 3) active double cancers 4) women who are currently pregnant, nursing, or plan to become pregnant 5) cases where the investigator disapproved of participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events, anti-tumor effect | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics of cisplatin, overall survival | — |
Countries
Japan
Outcome results
None listed