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Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery

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ClinicalTrials.gov Identifier: NCT03221608
Recruitment Status : Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborators:
Second Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
First Affiliated Hospital of Jinan University
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou General Hospital of Guangzhou Military Command
Tcm-integrated Cancer Center of Southern Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nanfang Hospital of Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Donglin Ren, Sixth Affiliated Hospital, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Surgery and HIPEC with Lobaplatin Procedure: Surgery without HIPEC Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery: A Multicentre Randomised Clinical Trial
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Procedure: Surgery without HIPEC
The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.
Other Name: Standard surgical treatment by laparoscopy or open approach.

Experimental: surgery and HIPEC
Standard surgical treatment and HIPEC with Lobaplatin.
Procedure: Surgery and HIPEC with Lobaplatin
The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).
Other Name: The combination of surgery and HIPEC with Lobaplatin




Primary Outcome Measures :
  1. Incidence of endoperitoneal recurrence at 36 months [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 3 years ]
  2. Disease-free survival (DFS) [ Time Frame: 5 years ]
  3. Overall survival (OS) [ Time Frame: 3 years ]
  4. Overall survival (OS) [ Time Frame: 5 years ]
  5. Quality of life [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire

  6. HIPEC toxicity rate [ Time Frame: 1 month ]
  7. HIPEC toxicity rate [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221608


Contacts
Contact: MeiJin Huang, MD 86-020-38250745 meijinhuang3@163.com
Contact: Wei Chen, MD 86-020-38250745 chenw47@mail.sysu.edu.cn

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Second Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
First Affiliated Hospital of Jinan University
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou General Hospital of Guangzhou Military Command
Tcm-integrated Cancer Center of Southern Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Nanfang Hospital of Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: MeiJin Huang, MD Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party: Donglin Ren, MD, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03221608     History of Changes
Other Study ID Numbers: zs6yhmjHIPEC2017
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Donglin Ren, Sixth Affiliated Hospital, Sun Yat-sen University:
Colorectal Cancer
HIPEC
Peritoneal Carcinomatosis
Lobaplatin

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases