Gastric cancer
Conditions
Interventions
Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 14 of each cycle (actual dose dependent upon BSA). Oncothermia for 1 hour
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma. 2.Cancer cell is proved by cytology for abdominal cavity by an operation, laparoscopy or abdominal tap within 28 days before registration. It is desirable for the biopsy of the peritoneum nodule. 3.Oral intake is possible or to perform nutritional management in enteral nutrition or total parenteral nutrition at home. 4.Age 20-79 years. 5.ECOG performance status 0 or 1. 6.Life expectancy estimated more than 3 months. 7.Bone marrow, liver, renal function by measurement data within 14th before registration. 1)Hgb>8.0 g/dL 2)WBC 3000-12,000/mm3 3)platelets> 70,000/mm3 4)Total bilirubin< 1.5 X UNL 5)AST (SGOT) and ALT (SGPT)< 100 IU/L 6)Creatinine: Lower than upper limit of the standard value 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1. Active double cancer 2. S-1 contraindication 3. to take flucytosine, phenytoin and warfarin potassium 4. History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80, other severe drug induced allergy 5. Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, uncontrolled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.). 6. to suffer active infections or acute inflammatory diseases 7. Patient with positive HBs antigen or positive HCV antibody 8. Patient with severe diarrhea 9. 10Pregnancy or lactation women, women with suspected pregnancy or men with willing to get pregnant. 11. Patient with psychosis or psychotic symptoms and judged to be difficult to determine participating clinical trial. 12. Patient with edema not to control with oral diuretics 13. patient with peripheral neuropathy more than Grade 3. 14. Positive for HIV antibody. 15.16 Patient with severe pleural or pericardial effusion and ascites impossible to control. 17. Definite contraindications for the use of corticosteroids. 18. patient with autoimmune diseases. 19. patient with more important non-curative factors rather than peritoneal metastasis. 20. Any subject judged by the investigator to be unfit for any reason to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine one year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative conversion rate of washing cytology of peritoneal cavity, CR rate of peritoneal metastasis, overall survival, progression free survival, response rate, the rate of conversion therapy, the rate of radical surgery, rate of adverse effects. | — |
Countries
Japan
Contacts
Public ContactMasayuki Kano
Chiba University Frontier Surgery
Outcome results
None listed