Clinical trial NCT04370925: Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
Official title: A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Colectomy
Hyperthermic intraperitoneal chemotherapy
Peritoneal carcinomatosis
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Sun Yat-sen University
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Guangdong Provincial People's Hospital
name: Meizhou People's Hospital
name: First People's Hospital of Foshan
name: Shantou Central Hospital
name: Jiangmen Central Hospital
name: Shenzhen Second People's Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: ZhuHai Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Hospital
name: Peking University Cancer Hospital & Institute
name: Peking University People's Hospital
name: Fudan University
name: The Second Affiliated Hospital of Chongqing Medical University
name: Chongqing University Cancer Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wuhan Union Hospital, China
name: Renmin Hospital of Wuhan University
name: Wuhan University
name: Sichuan Provincial People's Hospital
name: West China Hospital
name: The People's Hospital of Leshan
name: People's Hospital of Deyang City
name: Hebei Medical University Fourth Hospital
name: The First Affiliated Hospital of Nanchang University
name: The Affiliated Hospital Of Southwest Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: The Third People's Hospital of Chengdu
name: The Affiliated Tumor Hospital of Guangxi Medical University
First posted: 2020-05-01
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peritoneal recurrence free survival
timeFrame: 3-year
Secondary outcomes:
measure: Disease free survival
timeFrame: 3-year
measure: Overall survival
timeFrame: 5-year
measure: Liver metastatic rate
timeFrame: 3-year
measure: Number of participants with adverse events
timeFrame: Up to 1 month after the last chemotherapy cycle
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Foshan
country: China
facility: The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincal people's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Six Affiliated Hospital,Sun Yat-sen University
state: Guangdong
city: Jiangmen
country: China
facility: JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University
state: Guangdong
city: Meizhou
country: China
facility: MeiZhou People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Affiliated Shantou Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University
state: Guangdong
city: Nanning
country: China
facility: People's hospital of guangxi zhuang autonomous region
state: Guangxi Zhuang Autonomous Region
city: Nanning
country: China
facility: The Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi Zhuang Autonomous Region
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Wuhan
country: China
facility: Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy
state: Hubei
city: Wuhan
country: China
facility: Wuhan University Renmin Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chendu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: The Third Peoples' Hospital of Chengdu
state: Sichuan
city: Deyang
country: China
facility: People'S Hospital of Deyang City
state: Sichuan
city: Leshan
country: China
facility: Leshan people's Hospital
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated hospital of southwest medical university
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital，Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: