Malignant Neoplasm of Colorectum Clinical Trial
Official title:
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.
To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer,
patients are randomized into HIPEC group and control group. In HIPEC group, the patients
undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu.
Patients in the control group just undergo radical colorectal resection with lymphadenectomy.
Patients in both groups receive 8 cycles of postoperative chemotherapy (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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