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
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Updated on 19 February 2024
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adenocarcinoma
cancer treatment
systemic chemotherapy
peritoneal carcinomatosis
mitomycin
colectomy
colorectal adenocarcinoma
hyperthermic intraperitoneal chemotherapy
adjuvant
colorectal cancer

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, Rectal disorder
Age 18years - 70years
Treatment Radical colectomy, HIPEC, Systemic chemotherapy
Clinical Study IdentifierNCT04370925
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last Modified on19 February 2024

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
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adenocarcinoma
cancer treatment
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adjuvant
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