Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.

Official Title
-----------------
Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

Conditions
-----------------
Advanced Gastric Cancer With Serosal Invasion

Intervention / Treatment
-----------------
* Procedure: surgery
* Drug: adjuvant systemic chemotherapy
* Drug: Early postoperative intraperitoneal chemothgerapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven adenocarcinoma of the stomach preoperative suspicion of serosal invasion on the radiological examination candidate for curative resection of the stomach with D2 age from 19 to 70 year old Eastern Cooperative Oncology Group Performance status :0, 1, or 2 absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter serum Creatinine<1.5mg/dL total bilirubin <2 x upper normal limit, transaminase<3 x upper normal limit patients without previous administration of chemotherapeutic agent patients who agreed and signed to the informed consent form Exclusion Criteria: malignancy of the stomach except for adenocarcinoma history of hypersensitivity to 5-fluorouracil or mitomycin concomitant infectious disease active hepatitis or chronic liver disease history of psychotic disorders patients with disorders in the central nervous system history of other malignancy within 5 years history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction) patients with increased bleeding tendency pregnant or lactating female patients patient who did not agreed and signed to the informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1 | Procedure: surgery<br>* Total or subtotal gastrectomy with D2<br>Drug: adjuvant systemic chemotherapy<br>* adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid)<br>Drug: Early postoperative intraperitoneal chemothgerapy<br>* operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq<br>|
| Placebo Comparator: Arm B<br>curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1 | Procedure: surgery<br>* Total or subtotal gastrectomy with D2<br>Drug: adjuvant systemic chemotherapy<br>* adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapsed free survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced gastric cancer, serosal invasion, peritoneal recurrence, intraperitoneal chemotherapy