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 combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.
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 neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open and parallel group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
radical gastrectomy with D2 lymphadenectomy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
Wuhan University
Wuhan, Hubei, China
RECRUITINGoverall survival
From the date of surgery to the date of death or to the end of follow-up
Time frame: 5 years
progression-free survival
Time frame: 5 years
distant metastasis rate
Time frame: 5 years
peritoneal metastasis rate
Time frame: 5 years
local recurrence rate
Time frame: 5 years
complication rate
Time frame: 5 years
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