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
1 other identifier
interventional
688
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Jun 2020
Typical duration for phase_3 colorectal-cancer
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedStudy Start
First participant enrolled
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJune 16, 2020
April 1, 2020
3.9 years
April 8, 2020
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peritoneal recurrence free survival
Peritoneal recurrence free survival is calculated from the date of randomization to the date of record peritoneal recurrence(with or without other metastasis), ovarian metastasis, malignant ascites, or death from any cause, whichever occurred first.
3-year
Secondary Outcomes (4)
Disease free survival
3-year
Overall survival
5-year
Liver metastatic rate
3-year
Number of participants with adverse events
Up to 1 month after the last chemotherapy cycle
Study Arms (2)
Matched control
ACTIVE COMPARATORPatients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy
HIPEC
EXPERIMENTALPatients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical Universitylead
- Nanfang Hospital, Southern Medical Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Sixth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Meizhou People's Hospitalcollaborator
- First People's Hospital of Foshancollaborator
- Shantou Central Hospitalcollaborator
- Jiangmen Central Hospitalcollaborator
- Shenzhen Second People's Hospitalcollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
- ZhuHai Hospitalcollaborator
- Cancer Institute and Hospital, Chinese Academy of Medical Sciencescollaborator
- Beijing Hospitalcollaborator
- Peking University Cancer Hospital & Institutecollaborator
- Peking University People's Hospitalcollaborator
- Fudan Universitycollaborator
- The Second Affiliated Hospital of Chongqing Medical Universitycollaborator
- Chongqing University Cancer Hospitalcollaborator
- First Affiliated Hospital of Chongqing Medical Universitycollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Renmin Hospital of Wuhan Universitycollaborator
- Wuhan Universitycollaborator
- Sichuan Provincial People's Hospitalcollaborator
- West China Hospitalcollaborator
- The People's Hospital of Leshancollaborator
- People's Hospital of Deyang Citycollaborator
- Hebei Medical University Fourth Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- The Affiliated Hospital Of Southwest Medical Universitycollaborator
- The Affiliated Hospital of Xuzhou Medical Universitycollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- The Third People's Hospital of Chengducollaborator
- The Affiliated Tumor Hospital of Guangxi Medical Universitycollaborator
Study Sites (37)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University)
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Provincal people's Hospital
Guangzhou, Guangdong, 510080, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Six Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University
Jiangmen, Guangdong, China
MeiZhou People's Hospital
Meizhou, Guangdong, China
Affiliated Shantou Hospital of Sun Yat-sen University
Shantou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University
Zhuhai, Guangdong, China
People's hospital of guangxi zhuang autonomous region
Nanning, Guangxi, China
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy
Wuhan, Hubei, 430030, China
Wuhan University Renmin Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Third Peoples' Hospital of Chengdu
Chengdu, Sichuan, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
People'S Hospital of Deyang City
Deyang, Sichuan, China
Leshan people's Hospital
Leshan, Sichuan, China
The Affiliated hospital of southwest medical university
Luzhou, Sichuan, China
The Second Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
May 1, 2020
Study Start
June 4, 2020
Primary Completion
April 30, 2024
Study Completion
April 30, 2026
Last Updated
June 16, 2020
Record last verified: 2020-04