Patients with gastric cancer and peritoneal metastasis
Conditions
Interventions
TXL 50mg/m2 is administered on day 1 and day 8. And TS-1 80 mg/m2 is administered from day 1 to day 14 (14 days). One course is these 14days and subsequent no-treatment 7 days.
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically proven gastric cancer 2. advanced gastric cancer with peritoneal metastasis and/or ascites 1. unresectable due to peritoneal metastasis and/or ascites under X-ray diagnosis 2. recurrent gastric cancer under diagnosis of biopsy, cytology or X-ray 3. with and without mesurable lesions 4. patient who can take orally , 5. without any prior chemotherapy or radiation therapy 6. Age: 20-75 yo 7. written informed consent 8. expected survival period longer than 9 weeks 9. Performance status: 0-2 (ECOG criteria) 10. No obvious bone marrow function and sufficient renal/hepatic function a Hemoglobin 8.0 g/dl <= WBC: 4,000 /mm3 <= and =< 12,000/mm3 Neutrocyte: 2,000/mm3=< Platelet: 100,000/mm3 =< Total bilirubin: 1.5mg/dl => GOT, GPT: 100 IU/l => Creatinin: within normal range CRP: 10mg/dl =>
Exclusion criteria
Exclusion criteria: 1.with severe cavity fluid which needs drainage 2.with a central nerve symptoms 3.with fresh intestinal beeding 4.with active double cancers 5.with an allergic reaction against TS-1 or TXL 6.with severe allergy against medicine 7.with severe diseases (cardiac failure, arrhythmia, renal dysfunction, liver dysfunction, interstitial pneumonia, severe neural disorder, uncontrolled DM, intestinal obstruction, etc.) 8.under pregnancy or nursing 9.doctors' decision not to register
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Time To No oral intake Time To Progression Adverse Events | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed