Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results. This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum Phase 2: Intraperitoneal Paclitaxel with recommended dose
Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Dose determination (Phase 1)
Dosage determination of Intraperitoneal Paclitaxel
Time frame: 1 Year
Overall survival (Phase 2)
1 year Overall survival with determined dose from Phase 1
Time frame: 1 Year
Progression-free survival
1 year Progression-free survival
Time frame: 1 Year
Toxicity ratio
Toxicity occurrence ratio by CTCAE V.4
Time frame: 3 Years
Tumor response
Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system
Time frame: 3 Years
Conversion surgery ratio
Conversion surgery after stable disease or regression
Time frame: 3 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.