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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Procedure: Surgery and HIPEC with Lobaplatin Procedure: Surgery without HIPEC||Phase 3|
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.
The patients with colorectal cancer (T4N0-2M0) will undergo a curative resection by laparoscopy or open approach.
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- Incidence of endoperitoneal recurrence at 36 months [ Time Frame: 36 months ]
- 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 ]
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
|Contact: MeiJin Huang, MDfirstname.lastname@example.org|
|Contact: Wei Chen, MDemail@example.com|
|Principal Investigator:||MeiJin Huang, MD||Sixth Affiliated Hospital, Sun Yat-sen University|