Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
Primary Purpose
Colorectal Neoplasms
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Surgery and HIPEC with Lobaplatin
Surgery without HIPEC
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, HIPEC, Peritoneal Carcinomatosis, Lobaplatin
Eligibility Criteria
Inclusion Criteria:
- Histologically-proven colorectal adenocarcinoma
- Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
- Signed informed consent
- White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
- No bleeding diathesis or coagulopathy
- Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial
Exclusion Criteria:
- Liver and/or lung metastases
- Pregnant women or likely to be pregnant
- Severe hepatic and / or renal dysfunction
- Impossibility of an adequate follow-up
- Without history of cancer during last 5 years
- Other concurrent chemotherapy
- Severe or uncontrolled mental illness
- Patients with epilepsy required to be treated
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
surgery alone(open/laparoscopic)
surgery and HIPEC
Arm Description
The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).
Standard surgical treatment and HIPEC with Lobaplatin.
Outcomes
Primary Outcome Measures
Incidence of endoperitoneal recurrence at 36 months
Secondary Outcome Measures
Disease-free survival (DFS)
Disease-free survival (DFS)
Overall survival (OS)
Overall survival (OS)
Quality of life
To evaluate quality of life with EORTC QLQ-30 questionnaire
HIPEC toxicity rate
HIPEC toxicity rate
Full Information
NCT ID
NCT03221608
First Posted
July 17, 2017
Last Updated
July 17, 2017
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03221608
Brief Title
Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Cancer, HIPEC, Peritoneal Carcinomatosis, Lobaplatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgery alone(open/laparoscopic)
Arm Type
Active Comparator
Arm Description
The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).
Arm Title
surgery and HIPEC
Arm Type
Experimental
Arm Description
Standard surgical treatment and HIPEC with Lobaplatin.
Intervention Type
Procedure
Intervention Name(s)
Surgery and HIPEC with Lobaplatin
Other Intervention Name(s)
The combination of surgery and HIPEC with Lobaplatin
Intervention Description
The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).
Intervention Type
Procedure
Intervention Name(s)
Surgery without HIPEC
Other Intervention Name(s)
Standard surgical treatment by laparoscopy or open approach.
Intervention Description
The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.
Primary Outcome Measure Information:
Title
Incidence of endoperitoneal recurrence at 36 months
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
3 years
Title
Disease-free survival (DFS)
Time Frame
5 years
Title
Overall survival (OS)
Time Frame
3 years
Title
Overall survival (OS)
Time Frame
5 years
Title
Quality of life
Description
To evaluate quality of life with EORTC QLQ-30 questionnaire
Time Frame
3 years
Title
HIPEC toxicity rate
Time Frame
1 month
Title
HIPEC toxicity rate
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-proven colorectal adenocarcinoma
Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
Signed informed consent
White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
No bleeding diathesis or coagulopathy
Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial
Exclusion Criteria:
Liver and/or lung metastases
Pregnant women or likely to be pregnant
Severe hepatic and / or renal dysfunction
Impossibility of an adequate follow-up
Without history of cancer during last 5 years
Other concurrent chemotherapy
Severe or uncontrolled mental illness
Patients with epilepsy required to be treated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MeiJin Huang, MD
Phone
86-020-38250745
Email
meijinhuang3@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Chen, MD
Phone
86-020-38250745
Email
chenw47@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MeiJin Huang, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
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