Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery

NCT ID: NCT03221608

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-08-01

Brief Summary

This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.

Detailed Description

Background:

Colorectal cancer (CRC) is the third most common malignancy worldwide, nearly 1.4 million new cases every year, for about 694000 deaths. Surgery is the primary treatment and results in a cure rate of approximately 50% of the patients. However, recurrence following surgery is a major problem, the second most common site of recurrence was peritoneum, which was as a result of the intraperitioneal free cancer cells (FCC) and microscopic cancer (MC). The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the "peritoneal-plasma barrier" and "non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy". In recent years, hyperthermic intraperitioneal chemotherapy(HIPEC) has already been shown to be effective in improving the 5 year survival rate of colorectal cancer. However, lots of clinically studies for patients with colorectal cancer are advanced, it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer. The efficacy tend to be magnified when stage T4 patients account for less, confusing HIPEC for treatment of patients with advanced colorectal cancer. Therefore, the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients, ruling out the effects of different T stages on curative effect. The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer.

Study design： This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone (control group) or HIPEC (experimental group) after resection of the primary tumor, either by laparoscopy or open approach. Subsequently, all patients started mfolfox6 chemotherapy after operation in a month. Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded.

Study population:

The patients with colorectal cancer (T4N0-2M0) will undergo a curative resection by laparoscopy or open approach.

Intervention:

HIPEC equipment used in the perfusion fluid (Lobaplatin of 50mg completely dissolved in 3000ml saline solution) is headed to 43℃. Then, it is injected into the peritoneal cavity by flow velocity of 200-400ml/min for 60 minutes.

Outcomes:

Primary endpoint is incidence of endoperitoneal recurrence at 36 months. Secondary endpoints are disease-free survival, overall survival, incidence of peritoneal carcinomatosis at end of follow-up with or without concomitant liver/lung metastases, quality of life and morbidity rate.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

surgery alone(open/laparoscopic)

The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).

Group Type: ACTIVE_COMPARATOR

Surgery without HIPEC

Intervention Type: PROCEDURE

The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.

surgery and HIPEC

Standard surgical treatment and HIPEC with Lobaplatin.

Group Type: EXPERIMENTAL

Surgery and HIPEC with Lobaplatin

Intervention Type: PROCEDURE

The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).

Interventions

Surgery and HIPEC with Lobaplatin

The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).

Intervention Type: PROCEDURE

Surgery without HIPEC

The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.

Intervention Type: PROCEDURE

Other Intervention Names

The combination of surgery and HIPEC with Lobaplatin; Standard surgical treatment by laparoscopy or open approach.

Eligibility Criteria

Inclusion Criteria

1. Histologically-proven colorectal adenocarcinoma

2. Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0

3. Signed informed consent

4. White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3

5. No bleeding diathesis or coagulopathy

6. Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial

Exclusion Criteria

1. Liver and/or lung metastases

2. Pregnant women or likely to be pregnant

3. Severe hepatic and / or renal dysfunction

4. Impossibility of an adequate follow-up

5. Without history of cancer during last 5 years

6. Other concurrent chemotherapy

7. Severe or uncontrolled mental illness

8. Patients with epilepsy required to be treated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: collaborator

Tcm-integrated Cancer Center of Southern Medical University

UNKNOWN

Sponsor Role: collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Donglin Ren

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MeiJin Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Central Contacts

MeiJin Huang, MD

Role: CONTACT

meijinhuang3@163.com

86-020-38250745

Wei Chen, MD

Role: CONTACT

chenw47@mail.sysu.edu.cn

86-020-38250745

Other Identifiers

zs6yhmjHIPEC2017

Identifier Type: -

Identifier Source: org_study_id