Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis
NCT ID: NCT04370925
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
688 participants
INTERVENTIONAL
2020-06-04
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Matched control
Patients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy
Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
Systemic chemotherapy
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.
HIPEC
Patients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy
Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
HIPEC
HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.
Systemic chemotherapy
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.
Interventions
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Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
HIPEC
HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.
Systemic chemotherapy
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
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Sun Yat-sen University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Guangdong Provincial People's Hospital
OTHER
Meizhou People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Shantou Central Hospital
OTHER
Jiangmen Central Hospital
OTHER
Shenzhen Second People's Hospital
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
ZhuHai Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Beijing Hospital
OTHER_GOV
Peking University Cancer Hospital & Institute
OTHER
Peking University People's Hospital
OTHER
Fudan University
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Chongqing University Cancer Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Renmin Hospital of Wuhan University
OTHER
Wuhan University
OTHER
Sichuan Provincial People's Hospital
OTHER
West China Hospital
OTHER
The People's Hospital of Leshan
OTHER
People's Hospital of Deyang City
UNKNOWN
Hebei Medical University Fourth Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
The Third People's Hospital of Chengdu
OTHER
The Affiliated Tumor Hospital of Guangxi Medical University
UNKNOWN
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, 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, China
Guangdong Provincal people's Hospital
Guangzhou, Guangdong, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 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, 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, 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
Countries
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Central Contacts
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Facility Contacts
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M.M
Role: backup
Jiansi Chen
Role: primary
Jun Song, MD
Role: primary
Other Identifiers
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HIPEC-06
Identifier Type: -
Identifier Source: org_study_id
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