Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    688
  • sponsor
    Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Updated on 25 January 2021
mitomycin
systemic chemotherapy
adenocarcinoma
colorectal adenocarcinoma
hyperthermic intraperitoneal chemotherapy

Summary

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

Description

The effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. However, prophylactic HIPEC in colorectal cancer patients at high risk of metachronous peritoneal metastases remained controversial. In this study, patients with colorectal cancer cT4N0-2M0(AJCC/UICC staging system 8th edition) and planed to undergo intentionally colectomy (laparotomy, laparoscopyor robotic ) are randomized into HIPEC group and control group. In HIPEC group, closed HIPEC is performed with Mitomycin C(30mg/m2) at 43 C for 90 minutes, simultaneously or within 2 days after colectomy and followed by systemic chemotherapy. For the patients in the control group, systemic chemotherapy were administered after colectomy. The primary endpoint is peritoneal recurrence-free survival (pRFS) rate. Secondary end points include overall survival (OS) rate, disease free survival (DFS) rate, liver metastatic rate, toxic effects, quality of life scores. All efficacy analyses are conducted in the intention-to-treat population, per-protocol population and pT4 subgroups due to pathologic tumor invasion can not be acquired before HIPEC. Safety analysis include only patients who receive their randomly assigned treatment.

Details
Condition Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal disorder, Rectal Disorders, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, colorectal neoplasm, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment systemic chemotherapy, HIPEC, Radical colectomy
Clinical Study IdentifierNCT04370925
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 and 70 years
Nonpregnant or breast-feeding women
ECOG status 0-1
Colorectal adenocarcinoma or mucinous adenocarcinoma
Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - according to AJCC 8th edition) without previous anti-cancer treatment and R0 resection could be achieved
Laboratory tests within 2 weeks before RandomizationNeutrophil 2.0 /mm3, , platelets 100,000/mm3, hemoglobin90g/l, Alanine transaminase (ALT) and aspartate aminotransferase (AST) 2.5 ULN), total bilirubin(TBIL) 1.5 ULN, serum creatinine 1.5 ULN
Written informed consent

Exclusion Criteria

Rectal cancer below peritoneal reflection
Concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment)
Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation
Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction
Existence of distance metastasis during surgery (M1) or can not achieve R0 resection
Contraindiction of mitomycin c(chickenpox or shingles)
Poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note