gastric cancer with peritoneal metastasis
Conditions
Interventions
mFOLFOX6 on days 1 and 15 intraperitoneal paclitaxel on days 1, 8 and 15 in 28days
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically proven gastric adenocarcinoma 2) peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy 3) difficult to be treated with oral anticancer agents due to inadequate oral intake 4) no previous chemotherapy or previous chemotherapy less than one month without disease progression or severe adverse events 5) adequate organ functions(according to the laboratory data which was taken within 14 days before registration) neutrophil count > 1,500/mm3 hemoglobin > 8.0 g/dl platelet count > 100,000/mm3 serum transaminases < 100/UI total serum bilirubin < 2.0mg/dl creatinine clearance > 50mL/min 6) Eastern Cooperative Oncology Group performance status 0-2 7) HER2 negative or unknown 8) an expected survival period of more than 3 months. 9) age between 20 and 80 years 10) written informed consent
Exclusion criteria
Exclusion criteria: 1) metastasis to distant organ sites other than the peritoneum, ovary or abdominal lymph nodes 2) other active concomitant malignancies 3) massive ascites which requires frequent drainage for palliation other severe medical conditions 4) contraindication for fluorouracil, levofolinate, oxaliplatin or paclitaxel 5) past or current severe heart disease 6) severe complications such as interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, renal failure or liver cirrhosis 7) pregnant or nursing women 8) judged to be unfit to participate in this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival time to treatment failure response rate negative conversion rate on peritoneal cytology safety | — |
Countries
Japan
Contacts
Public ContactHironori Ishigami
The University of Tokyo Department of chemotherapy
Outcome results
None listed