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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430021
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Radical colorectal resection without HIPEC; Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)	Procedure: Radical colorectal resection; radical colorectal resection with lymphadenectomy; Drug: Oxaliplatin , Capecitabine; XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.; Drug: Normal saline , Cisplatin , 5-Fu
Experimental: Radical colorectal resection with 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)	Procedure: Radical colorectal resection; radical colorectal resection with lymphadenectomy; Drug: Oxaliplatin , Capecitabine; XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	From the date of surgery to the date of death or to the end of follow-up	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	5 years
distant metastasis rate	5 years
peritoneal metastasis rate	5 years
local recurrence rate	5 years
complication rate	5 years

Collaborators and Investigators

• Sponsor: Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Neoplasms; Hyperthermia; Fever; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Cisplatin; Capecitabine; Oxaliplatin
• Other Study ID Numbers: WuhanU_HIPEC_colon

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No