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

Phase 2

Completed

• Conditions: Malignant Neoplasm of Colorectum
• Interventions: Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Drug: Oxaliplatin , Capecitabine; Procedure: Radical colorectal resection; Drug: Normal saline , Cisplatin , 5-Fu

• Registration Number: NCT02830139
• Lead Sponsor: Wuhan University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Status Verified: 2020-03
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radical colorectal resection without HIPEC	Oxaliplatin , Capecitabine	Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
Radical colorectal resection with HIPEC	Oxaliplatin , Capecitabine	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)
Radical colorectal resection without HIPEC	Normal saline , Cisplatin , 5-Fu	Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
Radical colorectal resection with HIPEC	Radical colorectal resection	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)
Radical colorectal resection with HIPEC	Hyperthermic intraperitoneal chemotherapy (HIPEC)	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)
Radical colorectal resection without HIPEC	Radical colorectal resection	Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)

Primary Outcome Measures

Name	Time	Method
overall survival	5 years	From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

Name	Time	Method
distant metastasis rate	5 years
progression-free survival	5 years
peritoneal metastasis rate	5 years
local recurrence rate	5 years
complication rate	5 years

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China