S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Conditions
Interventions
CPT-11+CDDP arm: CPT-11(60mg/m2) day1 CDDP(30mg/m2) day1 Every 2 weeks
CPT-11 arm: CPT-11(150mg/m2) day1 Every 2 weeks
Sponsors
The Tokyo cooperative oncology group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.With pathologically proven gastric cancer 2. With at least one measurable lesion (RECIST) 3. S-1 failure for Patients with Advanced and Recurrent Gastric Cancer 4. No prior immunotherapy and radiotherapy 5. 2 weeks or more pass from first line chemotherapy ends. 6. 4 weeks or more pass from Operation(Only the case who operated) 7. ECOG performance status<=2 8. Age 20 years old or more 9. Life expectancy estimated>=12 weeks 10. Sufficient organ functions 11.With written IC
Exclusion criteria
Exclusion criteria: 1. a patient who received transfusion, blood products, or hematopoietic growth factors such as G-CSF within 7 days prior to the registration 2. S-1+CPT-11 combination therapy as the first line chemotherapy 3. Advanced gastric cancer that refuses operation 4. History of severe drug allergic reaction 5.serious pleural effusion or ascites 6.serious Infectious disease 7. Watery diarrhea 8. Intestinal obstruction or Intestines paralysis 9. Intestinal fresh hemorrhage 10. With serious lung disease 11.administering atazanavir sulfate 12. Symptomatic brain metastasis 13. Active secondary cancer 14. cardiac disease 15. psychiatric disease or nervous disease 16. preganat or nursing patients and patients who may be pregnant 17. Decision as ineligible by principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| OS TTF Anti-tumor Effect(Response rate) Adverse Event | — |
Countries
Japan
Outcome results
None listed