Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer

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.

Inclusion Criteria:

• Histological proved diagnosis of locally advanced colorectal cancer.
• No evidence of distant metastases or peritoneal metastases.
• Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
• Eligible for radical colorectal resection with 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