Advanced or recurrent gastric cancer
Conditions
Interventions
Arm A (tailored CPT-11 + S-1): CPT-11 (75mg/m2) is given biweekly for 4 weeks (one cycle). If the manifested toxicity defined by NCI-CTC criteria, is 0 or 1 (grade 0 for diarrhea) during the first c
body surface area <
1.25m2, 40mg
1.25-1.50m2, 50mg
=1.5m2, 60mg. S-1 is administered at the respective dose for 14 days, followed by a 14days rest period (one cycle).
Arm B (S-1): S-1 is given in the same dose of Arm A, and administered for 28 days,
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically demonstrated adenocarcinoma of the stomach 2) Failed operation or recurrence of gastric cancer 3) Measurable or assessable lesions 4) No prior therapy including radiation and/or chemotherapy except adjuvant chemotherapy after the preceding curative resection 5) Expected survival over 12 weeks 6) ECOG performance status 0-1 7) Sufficient organ functions 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of using S-1 2) Medical history of allergy or hypersensitivity reactions to any drug 3) Serious effusion of cancerous fluids such as pleural effusion and/or ascites 4) Serious infectious disease 5) Diarrhea 6) Ileus or colon dysfunction 7) Lung fibrosis 8) Intake of flucitosine 9) Synchronous or metachronous or other types of malignancies 10) Uncontrollable diabetes mellitus 11) Serious heart disease 12) Serious psychological disease 13) Pregnancy 14) Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response duration, Time to progression (TTP), Overall survival, Incidence of adverse events | — |
Countries
Japan
Outcome results
None listed