Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

Detailed Description
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To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Official Title
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A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy

Conditions
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Malignant Neoplasm of Stomach

Intervention / Treatment
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* Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
* Procedure: D2 radical gastrectomy
* Other: SOX postoperative chemotherapy
* Other: XELOX postoperative chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proved diagnosis of locally advanced gastric cancer. No evidence of distant metastases or peritoneal metastases. Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. Eligible for radical gastrectomy with D2 lymphadenectomy. Have not received cytotoxic chemotherapy or radiotherapy. Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: Existence of distant metastasis or peritoneal metastasis during surgery (M1). Any previous chemotherapy or radiotherapy Active systemic infections Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. Female patients who are pregnant or breast feeding

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Radical gastrectomy without HIPEC<br>Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX) | Procedure: D2 radical gastrectomy<br>* radical gastrectomy with D2 lymphadenectomy<br>Other: SOX postoperative chemotherapy<br>* Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.<br>Other: XELOX postoperative chemotherapy<br>* Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.<br>|
| Experimental: Radical gastrectomy with HIPEC<br>Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX) | Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)<br>* Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.<br>Procedure: D2 radical gastrectomy<br>* radical gastrectomy with D2 lymphadenectomy<br>Other: SOX postoperative chemotherapy<br>* Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.<br>Other: XELOX postoperative chemotherapy<br>* Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | From the date of surgery to the date of death or to the end of follow-up | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 5 years | 
| distant metastasis rate |  | 5 years | 
| peritoneal metastasis rate |  | 5 years | 
| local recurrence rate |  | 5 years | 
| complication rate |  | 5 years |