Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
- Conditions
- Malignant Neoplasm of Stomach
- Registration Number
- NCT02528110
- Lead Sponsor
- Wuhan University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 local recurrence rate 5 years progression-free survival 5 years complication rate 5 years distant metastasis rate 5 years peritoneal metastasis rate 5 years
Trial Locations
- Locations (1)
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University🇨🇳Wuhan, Hubei, China