Advanced/Recurrent gastric cancer which has no response to S-1
Conditions
Interventions
CPT-11(60mg/m2) and CDDP(30mg/m2) are administered on day 1, 15, 29, and 43, and more courses on every 14 days if patients can be tolerant and have response (effective). One course takes 14 days.
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. gastric carcinoma diagnosed histologically 2. advanced and/or recurrent gastric cancer 3. gastric cancer which has no response to prior TS-1 therapy a. progression during or after TS-1 therapy b. recurrence within 26 weeks of the end of postoperative TS-1 therapy 4. without surgical operation or any therapies other than TS-1 5. with TS-1 therapy more than 4 weeks 6. more than 4 weeks rest after TS-1 therapy 7. with measurable lesion 8. age between 20 and 75 years old 9. Performance Status 0-2 (ECOG Classification) 10. more than 13 weeks of expected survival 11. with good function in the important organs WBC: 4,000 <= and =>12,000/mm3 Neutrophil >= 2,000/mm3 Platelet >= 100,000 /mm3 Hb >= 8.0 g/dl sGOT, sGPT: < normal range x 2.5 T Bil.: <= 1.5 mg/dl sCreatinin <=Clearlance 12. written informed consent
Exclusion criteria
Exclusion criteria: 1. with interstitial pneumonitis or pulmonary fibrosis 2. much fluid in the cavity 3. active double cancer except carcinoma in situ or skin cancer 4. with infectious disease which needs treatment 5. intestinal paralysis or ileus 6. watery stool (diarrhea) 7. uncontrolled DM or DM being treated by insulin 8. with ischemic cardiac disease 9. with psycologic disorder which disturbs recruiting to the study 10. with severe diseases (cardiac failure, liver dysfunction or renal dysfunction) 11. pregnant and/or nursing women 12. present and/or past allergy against medicines 13. doctor's decision not to recruit to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor response (Response Rate, Duration of response) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Adverse Events 2) Overall survival 3) Progression free survival;PFS 4) Time to treatment failure;TTF 5) Relative dose intensity | — |
Countries
Japan
Outcome results
None listed