INtraPeritoneal Administration of ChemoTherapeutic agent Trial

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2009
INTERVENTION: 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. CONDITION: gastric cancer (large type 3 or type 4 cancer, or cancer with CY1 or P1 status who nevertheless will be treated by gastrectomy) PRIMARY OUTCOME: 2 year survival rate SECONDARY OUTCOME: toxicity; progression free survival; overall survival 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
Epistemonikos ID: d5701bbd60d34450eb5febf076175f7dd6c4634d
First added on: Aug 22, 2024