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Trial record 3 of 1521 for:    Recruiting, Not yet recruiting, Available Studies | "Colorectal Neoplasms"

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

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date July 18, 2017
Estimated Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
Incidence of endoperitoneal recurrence at 36 months [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • Disease-free survival (DFS) [ Time Frame: 3 years ]
  • Disease-free survival (DFS) [ Time Frame: 5 years ]
  • Overall survival (OS) [ Time Frame: 3 years ]
  • Overall survival (OS) [ Time Frame: 5 years ]
  • Quality of life [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire
  • HIPEC toxicity rate [ Time Frame: 1 month ]
  • HIPEC toxicity rate [ Time Frame: 6 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: Surgery without HIPEC
  • Experimental: surgery and HIPEC
    Standard surgical treatment and HIPEC with Lobaplatin.
    Intervention: Procedure: Surgery and HIPEC with Lobaplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2024
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MeiJin Huang, MD 86-020-38250745 meijinhuang3@163.com
Contact: Wei Chen, MD 86-020-38250745 chenw47@mail.sysu.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221608
Other Study ID Numbers  ICMJE zs6yhmjHIPEC2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Donglin Ren, Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor  ICMJE Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: MeiJin Huang, MD Sixth Affiliated Hospital, Sun Yat-sen University
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP