Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.

Official Title
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A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy

Conditions
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Advanced Gastric Adenocarcinoma

Intervention / Treatment
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* Procedure: D2 lymphadenectomy
* Procedure: Systemic chemotherapy
* Procedure: HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 < age ≤ 65 years old Male or Non pregnant female The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan) Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy White blood cells > 4,000/mm3 neutrophils ≥ 1,500/mm3 platelets ≥ 100,000/mm3 hemoglobin>9g/l Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN) total bilirubin (TBIL) < 1.5 times ULN serum creatinine < 1 times ULN Having given written informed consent prior to any procedure related to the study Exclusion Criteria: Existence of macroscopic peritoneal implants Prior malignant tumors with detectable signs of recurrence or distant metastasis Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50% Receiving other cytotoxic chemotherapy High grade of intra-abdominal adhesions Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: D2 lymphadenectomy and HIPEC and Systemic chemotherapy<br>Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. | Procedure: D2 lymphadenectomy<br>* The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.<br>Procedure: Systemic chemotherapy<br> <br> Procedure: HIPEC<br> <br> * Other names: hyperthermic intraperitoneal chemoperfusion;|
| Placebo Comparator: D2 lymphadenectomy+Systemic chemotherapy<br>8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. | Procedure: D2 lymphadenectomy<br>* The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.<br>Procedure: Systemic chemotherapy<br> <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 |
| --- | --- | --- |
| Recurrence-free survival | From the date of surgery to the date of recurrence or to the end of follow-up | 5 years | 
| Locoregional-free survival | From the date of surgery to the date of locoregional recurrence or to the end of follow-up | 5 years | 
| Hepatic metastases-free survival | From the date of surgery to the date of recurrence or to the end of follow-up | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine