Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

Conditions
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Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel, mFOLFOX6

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: mFOLFOX6 regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric Cancer with Peritoneal Carcinomatosis<br>Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin) | Drug: Paclitaxel<br>* 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<br>* Other names: (Genexol®);Drug: mFOLFOX6 regimen<br>* Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose determination (Phase 1) | Dosage determination of Intraperitoneal Paclitaxel | 1 Year | 
| Overall survival (Phase 2) | 1 year Overall survival with determined dose from Phase 1 | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 1 year Progression-free survival | 1 Year | 
| Toxicity ratio | Toxicity occurrence ratio by CTCAE V.4 | 3 Years | 
| Tumor response | Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system | 3 Years | 
| Conversion surgery ratio | Conversion surgery after stable disease or regression | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Peritoneal carcinomatosis, Intraperitoneal chemotherapy, Paclitaxel, FOLFOX