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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830139
• Other study ID #: WuhanU_HIPEC_colon
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Fever
• Malignant Neoplasm of Colorectum
• Neoplasms

Intervention

Procedure:
• Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.
• Radical colorectal resection
radical colorectal resection with lymphadenectomy

Drug:
• Oxaliplatin , Capecitabine
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
• Normal saline , Cisplatin , 5-Fu

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	From the date of surgery to the date of death or to the end of follow-up	5 years
Secondary	progression-free survival		5 years
Secondary	distant metastasis rate		5 years
Secondary	peritoneal metastasis rate		5 years
Secondary	local recurrence rate		5 years
Secondary	complication rate		5 years