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

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Enrolling; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: Radical colectomy; Procedure: HIPEC; Drug: Systemic chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04370925

HIPEC-06

Details and patient eligibility

About

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.

Full 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, laparoscopy，or 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.

Enrollment: 688 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 Randomization：Neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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688 participants in 2 patient groups

Matched control

Active Comparator group

Description:

Patients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy

Treatment:

Procedure: Radical colectomy

Drug: Systemic chemotherapy

HIPEC

Experimental group

Description:

Patients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy

Treatment:

Procedure: HIPEC

Procedure: Radical colectomy

Drug: Systemic chemotherapy