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

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: Advanced Gastric Adenocarcinoma

Treatments: Procedure: HIPEC; Procedure: Systemic chemotherapy; Procedure: D2 lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02240524

2014514

Details and patient eligibility

About

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.

Enrollment: 582 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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582 participants in 2 patient groups, including a placebo group

D2 lymphadenectomy and HIPEC and Systemic chemotherapy

Experimental group

Description:

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.

Treatment:

Procedure: Systemic chemotherapy

Procedure: D2 lymphadenectomy

Procedure: HIPEC

D2 lymphadenectomy+Systemic chemotherapy

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Systemic chemotherapy

Procedure: D2 lymphadenectomy