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

Phase 3

• Conditions: Advanced Gastric Adenocarcinoma
• Interventions: Procedure: D2 lymphadenectomy; Procedure: Systemic chemotherapy; Procedure: HIPEC

• Registration Number: NCT02240524
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-03
• Study Start: 2014-07
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-12
• Last Update Submitted: 2014-09-12
• Study First Posted: 2014-09-15
• Last Update Posted: 2014-09-15
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 582

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D2 lymphadenectomy and HIPEC and Systemic chemotherapy	D2 lymphadenectomy	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.
D2 lymphadenectomy and HIPEC and Systemic chemotherapy	HIPEC	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.
D2 lymphadenectomy and HIPEC and Systemic chemotherapy	Systemic chemotherapy	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.
D2 lymphadenectomy+Systemic chemotherapy	D2 lymphadenectomy	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.
D2 lymphadenectomy+Systemic chemotherapy	Systemic chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

Name	Time	Method
Hepatic metastases-free survival	5 years	From the date of surgery to the date of recurrence or to the end of follow-up
Recurrence-free survival	5 years	From the date of surgery to the date of recurrence or to the end of follow-up
Locoregional-free survival	5 years	From the date of surgery to the date of locoregional recurrence or to the end of follow-up

Trial Locations

Locations (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China