Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel, mFOLFOX6
Conditions
Keywords
Gastric cancer, Peritoneal carcinomatosis, Intraperitoneal chemotherapy, Paclitaxel, FOLFOX
Brief summary
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.
Interventions
DRUGPaclitaxel
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
DRUGmFOLFOX6 regimen
Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)
Sponsors
Boryung Pharmaceutical Co., Ltd
B. Braun Korea Co., Ltd.
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy proven adenocarcinoma of gastric origin, primary or recurrent * Identification of Peritoneal seeding by CT or diagnostic laparoscopy * Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic * No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer * Labs adequate for chemotherapy (within 2 weeks of enrollment) * Absolute Neutrophil Count: ≧ 1,500/mm³ * Hemoglobin level: ≧ 8.0g/dL * Platelet Count: ≧ 10×104/mm³ * AST (GOT), ALT (GPT): ≦ 100U/L * Total Bilirubin: ≦ 2.0mg/dL * Creatinine Clearance (CCl): ≧ 50mL/min * ECOG 0 - 2 * Her-2 negative on endoscopic biopsy * Age ≧ 20, \< 80 * Signed Informed consent form
Exclusion criteria
* Patients with other major medical disease or malignant tumors other than gastric cancer * Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel * Pregnant, breast-feeding women or with birth plan * Patients refusing treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose determination (Phase 1) | 1 Year | Dosage determination of Intraperitoneal Paclitaxel |
| Overall survival (Phase 2) | 1 Year | 1 year Overall survival with determined dose from Phase 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 1 Year | 1 year Progression-free survival |
| Toxicity ratio | 3 Years | Toxicity occurrence ratio by CTCAE V.4 |
| Tumor response | 3 Years | Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system |
| Conversion surgery ratio | 3 Years | Conversion surgery after stable disease or regression |
Countries
South Korea
Outcome results
None listed