Malignant Neoplasm of Stomach Clinical Trial
Official title:
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
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.
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.
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