Status:
RECRUITING
Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Sun Yat-sen University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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.
Detailed Description
The effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. Howe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT04370925
Start Date
June 4 2020
End Date
April 30 2026
Last Update
June 16 2020
Active Locations (37)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Beijing Hospital
Beijing, Beijing Municipality, China
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
4
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China