Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
688 participants
Jun 4, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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
Interventions
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.
Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients. CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable.
Locations(37)
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NCT04370925