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

Wuhan University

Status and phase: Completed; Phase 2

Conditions: Malignant Neoplasm of Colorectum

Treatments: Drug: Normal saline , Cisplatin , 5-Fu; Procedure: Radical colorectal resection; Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Drug: Oxaliplatin , Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02830139

WuhanU_HIPEC_colon

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Radical colorectal resection without HIPEC

Sham Comparator group

Description:

Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)

Treatment:

Procedure: Radical colorectal resection

Drug: Normal saline , Cisplatin , 5-Fu

Drug: Oxaliplatin , Capecitabine

Radical colorectal resection with HIPEC

Experimental group

Description:

Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)

Treatment:

Procedure: Radical colorectal resection

Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)

Drug: Oxaliplatin , Capecitabine