Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04370925
Other study ID # HIPEC-06
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 4, 2020
Est. completion date April 30, 2026

Study information

Verified date April 2020
Source Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Contact Shuzhong Cui, MD
Phone 086-13802513800
Email cuishuzhong@gzhmu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 688
Est. completion date April 30, 2026
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Procedure:
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.
Drug:
Systemic chemotherapy
Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage ? 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 stage?patiens, regimens recommend by NCCN guide line(2019 v1) are acceptable.

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing
China Peking University Cancer Hospital & Institute Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China West China Hospital,Sichuan University Chendu Sichuan
China Sichuan Provincial People's Hospital Chengdu Sichuan
China The Third Peoples' Hospital of Chengdu Chengdu Sichuan
China Chongqing Cancer Hospital Chongqing Chongqing
China First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China People'S Hospital of Deyang City Deyang Sichuan
China The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University) Foshan Guangdong
China Affiliated Cancer Hospital & Institute of Guangzhou Medical University Guangzhou Guangdong
China Guangdong Provincal people's Hospital 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 Sun Yat-sen University Cancer Center 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 The Second Affiliated Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang
China JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University Jiangmen Guangdong
China Leshan people's Hospital Leshan Sichuan
China The Affiliated hospital of southwest medical university Luzhou Sichuan
China MeiZhou People's Hospital Meizhou Guangdong
China the First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China People's hospital of guangxi zhuang autonomous region Nanning Guangxi Zhuang Autonomous Region
China The Affiliated Tumor Hospital of Guangxi Medical University Nanning Guangxi Zhuang Autonomous Region
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Affiliated Shantou Hospital of Sun Yat-sen University Shantou Guangdong
China Shenzhen Second People's Hospital Shenzhen Guangdong
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 Zhongshan City People's Hospital Zhongshan Guangdong
China Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University Zhuhai Guangdong

Sponsors (37)

Lead Sponsor Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Beijing Cancer Hospital, Beijing Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chongqing University Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Fudan University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial People's Hospital, Hebei Medical University Fourth Hospital, Jiangmen Central Hospital, Meizhou People's Hospital, Nanfang Hospital of Southern Medical University, Peking University People's Hospital, People's Hospital of Guangxi, People’s Hospital of Deyang City, Renmin Hospital of Wuhan University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shantou Central Hospital, Shenzhen Second People's Hospital, Sichuan Provincial People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University, The Affiliated Hospital Of Southwest Medical University, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Tumor Hospital of Guangxi Medical University, The First Affiliated Hospital of Nanchang University, The People's Hospital of Leshan, The Second Affiliated Hospital of Chongqing Medical University, The Third People's Hospital of Chengdu, West China Hospital, Wuhan Union Hospital, China, Wuhan University, Zhongshan People's Hospital, Guangdong, China, ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Overall survival Overall survival is calculated from randomization to death from any cause. 5-year
Secondary 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
Secondary Number of participants with adverse events Incidence of acute and late toxicity Up to 1 month after the last chemotherapy cycle
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A