gastric cancer (large type 3 or type 4 cancer, or cancer with CY1 or P1 status who nevertheless will be treated by gastrectomy)
Conditions
Interventions
intraperitoneal paclitaxel administration at 60 mg/m2 on days 0, 14, 21, 28, 42, 49, 56.
intravenous paclitaxel administration at 80 mg/m2 on days 0, 14, 21, 28, 42, 49, 56.
Sponsors
Non profit organization ECRIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological diagnosis of adenocarcinoma of the stomach 2) Macroscopically type 3 or type 4, or are suspected to suffer from peritoneal metastasis 3) Macroscopically type 3 will need to exceed 8 cm in diameter either by the endoscopy or double contrast study 4) No bulky nodal metastasis, hepatic , lung metastasis, massive ascites, thoracic effusion, other distant metastasis by computerized tomography 5) No clinical evidence of distant metastasis 6) Previously untreated by chemotherapy or radiation 7) ECOG Performance statsu 0 or 1 8) adequate organ functions 9) No serious arrhythmia on ECG within 3 months of registration 10) Surgery planned less than 1 month ahead 11) Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1) Serious cardiac, hepatic, and pulmonary comorbidities or uncontrollable diabetes mellitus. Active gastrointestinal bleeding or bowel obstruction 2) Active second malignancy either found simultaneously or within 5 years from the diagnosis of gastric cancer 3) Suffering from infection 4) Under steroid therapy 5) Has wishes to become pregnant 6) Under mental disorder 7) allergy to the ingredients of paclitaxel injection 8) severe drug allergy 9) Peripheral neural disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity progression free survival overall survival | — |
Countries
Japan
Contacts
Public ContactYasuhiro Kodera
Nagoya University Graduate School of Medicine Department of Surgery II
Outcome results
None listed