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

Primary Purpose

Malignant Neoplasm of Colorectum

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Radical colorectal resection

Oxaliplatin , Capecitabine

Normal saline , Cisplatin , 5-Fu

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Colorectum

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Radical colorectal resection without HIPEC

Radical colorectal resection with HIPEC

Arm Description

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

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)

Outcomes

Primary Outcome Measures

overall survival

From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

progression-free survival

distant metastasis rate

peritoneal metastasis rate

local recurrence rate

complication rate

Full Information

NCT ID

NCT02830139

First Posted

July 8, 2016

Last Updated

March 16, 2020

Sponsor

Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT02830139

Brief Title

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

Official Title

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm of Colorectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radical colorectal resection without HIPEC

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Radical colorectal resection with HIPEC

Arm Type

Experimental

Arm 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)

Intervention Type

Procedure

Intervention Name(s)

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Intervention Description

Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.

Intervention Type

Procedure

Intervention Name(s)

Radical colorectal resection

Intervention Description

radical colorectal resection with lymphadenectomy

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin , Capecitabine

Intervention Description

XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Intervention Type

Drug

Intervention Name(s)

Normal saline , Cisplatin , 5-Fu

Primary Outcome Measure Information:

Title

overall survival

Description

From the date of surgery to the date of death or to the end of follow-up

Time Frame

5 years

Secondary Outcome Measure Information:

Title

progression-free survival

Time Frame

5 years

Title

distant metastasis rate

Time Frame

5 years

Title

peritoneal metastasis rate

Time Frame

5 years

Title

local recurrence rate

Time Frame

5 years

Title

complication rate

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430021

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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