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| Name | Class |
|---|---|
| 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 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matched control | Active Comparator | Patients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy |
|
| HIPEC | Experimental | Patients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical colectomy | Procedure | Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Disease free survival is calculated from randomization to to the date of a first relapse, the diagnosis of a secondary colorectal cancer after the initial diagnosis, or death from any cause, whichever occurred first. | 3-year |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuzhong Cui, MD | Contact | 086-13802513800 | cuishuzhong@gzhmu.edu | |
| Tianpei Guan, MD | Contact | 086-13660895051 | dr_guan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| 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 |
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| HIPEC | Procedure | HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes. |
|
| Systemic chemotherapy | Drug | 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. |
|
Overall survival is calculated from randomization to death from any cause. |
| 5-year |
| Liver metastatic rate | Liver metastatic rate is calculated from randomization to to the date of liver metastasis with or without other organ metastasis. | 3-year |
| Number of participants with adverse events | Incidence of acute and late toxicity | Up to 1 month after the last chemotherapy cycle |
| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University Cancer Hospital & Institute | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Chongqing Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | China |
|
| First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University) | Not yet recruiting | Foshan | Guangdong | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| Guangdong Provincal people's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
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| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510095 | China |
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| Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Nanfang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Six Affiliated Hospital,Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University | Not yet recruiting | Jiangmen | Guangdong | China |
|
| MeiZhou People's Hospital | Recruiting | Meizhou | Guangdong | China |
|
| Affiliated Shantou Hospital of Sun Yat-sen University | Not yet recruiting | Shantou | Guangdong | China |
|
| Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
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| Zhongshan City People's Hospital | Not yet recruiting | Zhongshan | Guangdong | China |
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| Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University | Not yet recruiting | Zhuhai | Guangdong | China |
|
| People's hospital of guangxi zhuang autonomous region | Not yet recruiting | Nanning | Guangxi | China |
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| The Affiliated Tumor Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | China |
|
| Hebei Medical University Fourth Hospital | Not yet recruiting | Shijiazhuang | Hebei | China |
|
| Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Wuhan University Renmin Hospital | Not yet recruiting | Wuhan | Hubei | China |
|
| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | China |
|
| the First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
|
| The Third Peoples' Hospital of Chengdu | Not yet recruiting | Chengdu | Sichuan | China |
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| West China Hospital，Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| People'S Hospital of Deyang City | Not yet recruiting | Deyang | Sichuan | China |
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| Leshan people's Hospital | Not yet recruiting | Leshan | Sichuan | China |
|
| The Affiliated hospital of southwest medical university | Not yet recruiting | Luzhou | Sichuan | China |
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| The Second Affiliated Hospital，Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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