Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

Study Overview
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Brief Summary
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Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

Detailed Description
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The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A). The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Official Title
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Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction

Conditions
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Malignant Neoplasm of Stomach

Intervention / Treatment
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* Procedure: intraperitoneal chemoperfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG. No evidence of distant metastases preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage Written informed consent is obtained prior to commencement of trial treatment Exclusion Criteria: Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer Active systemic infections Patients with known interstitial lung disease with New York Heart Association classification > 2 Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure cardiac arrhythmia Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/ Active vaccination within 6 weeks prior to randomisation Active hepatitis B or C infection Female patients who are pregnant or breast feeding Missing of capacity to contract contraindication to the drugs which are used in the trial Participation in another therapeutic clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: without HIPEC<br>Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX). | |
| Experimental: with HIPEC<br>Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L ) | Procedure: intraperitoneal chemoperfusion<br>* HIPEC with cisplatin at the time of D2 radical surgery<br>* Other names: HIPEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival [ Time Frame: Death or 2 years ] | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | 30 days | 
| time to progress | follow up every 3 months till 24 months end of study | 24 months | 
| time to distant metastasis | time to other distant metastases follow up every 3 months till 24 months | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, intraperitoneal chemoperfusion