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

Wuhan University

Status and phase: Completed; Phase 2

Conditions: Malignant Neoplasm of Stomach

Treatments: Other: SOX postoperative chemotherapy; Procedure: D2 radical gastrectomy; Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Other: XELOX postoperative chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02528110

WuhanU_HIPEC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Radical gastrectomy without HIPEC

Sham Comparator group

Description:

Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)

Treatment:

Other: XELOX postoperative chemotherapy

Procedure: D2 radical gastrectomy

Other: SOX postoperative chemotherapy

Radical gastrectomy with HIPEC

Experimental group

Description:

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)

Treatment:

Other: XELOX postoperative chemotherapy

Procedure: D2 radical gastrectomy

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)

Other: SOX postoperative chemotherapy