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Colorectal CancerPhase 3NCT04370925

Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

A Phase 3 study testing Radical colectomy, HIPEC and Systemic chemotherapy in people with Colorectal Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 37 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Radical colectomy, HIPEC and Systemic chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
688 participants
Where
37 sitesChina
Study dates
4 Jun 2020to 30 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

37 sites in 1 country.

Shuzhong Cui, MD contact

086-13802513800

cuishuzhong@gzhmu.edu

Tianpei Guan, MD contact

086-13660895051

dr_guan@126.com

37 sites in 1 country

China37 sites, 37 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Bin Liang, MD, 0086-136-8144-4694, 13681444694@163.com

    Bin Liang, MD

    Not yet recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality

    Gang Zhao, MM, 13910714396, njg656@163.com

    Gang Zhao, MM

    Not yet recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Xishan Wang, MD, 086-13552367779, Wxshan1208@126.com

    Xishan Wang, MD

    Not yet recruiting

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality

    Aiwen Wu, MD, 086-13911577190, wuaw@sina.com

    Qiushi Dong, MM

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Minghui Pang, MD, 0086-134-0282-1952, pangmh2000@163.com

    Minghui Pang, MD

    Recruiting

  • The Third Peoples' Hospital of Chengdu

    Chengdu, Sichuan

    Yanjun Liu, MD, 365184541@qq.com

    Yanjun Liu, MD

    Not yet recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Ziqiang Wang, MD, 086-18980602028, wangzqzyh@163.com

    Ziqiang Wang, MD

    Not yet recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

    Hao Sun, MD, 086-13508370438, sunhao68@sina.com

    Hao Sun, MD

    Not yet recruiting

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Zhengqiang Wei, MD, 086-13228675636, 384535713@qq.com

    Zhengqiang Wei, MD

    Not yet recruiting

  • Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Jijian Wang, MD, 086-13908304080, Wangjj1963@163.com

    Jijian Wang, MD

    Not yet recruiting

  • People'S Hospital of Deyang City

    Deyang, Sichuan

    Gang Mai, MD, 086-15283831000, 1026823581@qq.com

    Gang Mai, MD

    Not yet recruiting

  • The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University)

    Foshan, Guangdong

    Longqing Cheng, MM, 18038863563, 13702939022@139.com

    Longqing Cheng, MM

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhizhong Pan, MD, 086-13719388166, panzz@sysucc.org.cn

    Zhizhong Pan, MD

    Not yet recruiting

  • Guangdong Provincal people's Hospital

    Guangzhou, Guangdong, 510080

    Yong Li, MD, 0086-138-2217-7479, liyong@gdph.org.cn

    M.M

    Not yet recruiting

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Shuzhong Cui, MD, 0086-138-0251-3800, cuishuzhong@126.com

    Tianpei Guan, MD, 0086-136-6089-5051, dr_guan@126.com

    Recruiting

  • Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510120

    Wei Wang, MD, 0086-13922255515, ww1640@yeah.net

    Wei Wang, MD

    Not yet recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Haijun Deng, MD, 0086-13189096629, navyd999@163.com

    Haijun Deng, MD

    Not yet recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Chuangqi Chen, MD, 086-13719334878, 2632864588@qq.com

    Chuangqi Chen, MD

    Not yet recruiting

  • The Six Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong

    Meijin Huang, MD, 086-13924073322, 13924073322@139.com

    Meijin Huang, MD

    Not yet recruiting

  • The Second Affiliated Hospital，Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Kefeng Ding, MD, 086-13906504783, dingkefeng@zju.edu.cn

    Kefeng Ding, MD

    Not yet recruiting

  • JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University

    Jiangmen, Guangdong

    Chao Li, BD, 13902888981, Lichao8981@163.com

    Chao Li, BD

    Not yet recruiting

  • Leshan people's Hospital

    Leshan, Sichuan

    Jian Wang, BD, 086-13808138498, Wjls1963@sina.com

    Jian Wang, BD

    Not yet recruiting

  • The Affiliated hospital of southwest medical university

    Luzhou, Sichuan

    Liang Xu, MM, 086-13708289307, XUL1104@163.com

    Liang Xu, MM

    Not yet recruiting

  • MeiZhou People's Hospital

    Meizhou, Guangdong

    Zuguang Zuguang, MM, 086-13502523063, wuzg1913@163.com

    Zuguang Zuguang, MM

    Recruiting

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Zhigang Jie, MD, 086-13707918042, jiezg123@126.com

    Zhigang Jie, MD

    Not yet recruiting

  • People's hospital of guangxi zhuang autonomous region

    Nanning, Guangxi

    Wei Mai, BS, 13977154858@139.com

    Wei Mai, BS

    Not yet recruiting

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi

    Jiansi Chen

    Jiansi Chen

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Guoxiang Cai, MD, 086-18017312703, gxcai@fudan.edu.cn

    Guoxiang Cai, MD

    Not yet recruiting

  • Affiliated Shantou Hospital of Sun Yat-sen University

    Shantou, Guangdong

    Xiaozhong Wang, MM, 086-13809658922, 103776710@qq.com

    Xiaozhong Wang, MM

    Not yet recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

    Haitao Zhang, MM, 13903025325, www.13903025325.@163.com

    Haitao Zhang, MM

    Not yet recruiting

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei

    Bin Yu, MM, 13832329699, yubinli_68@163.com

    Bin Yu, MM

    Not yet recruiting

  • Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy

    Wuhan, Hubei, 430030

    Kaixiong Tao, MD, 0086-135-0715-5452, tao_kaixiong@163.com

    Kaixiong Tao, MD

    Recruiting

  • Wuhan University Renmin Hospital

    Wuhan, Hubei

    Yongbin Zheng, MD, 086-13871189698, 13871189698@163.com

    Yongbin Zheng, MD

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Congqing Jiang, MD, 086-18971525805, wb002554@whu.edu.cn

    Congqing Jiang, MD

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Jun Song, MD, 15105200058

    Jun Song, MD

    Not yet recruiting

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong

    Yao Wang, MD, 18826006277, tongjimc@126.com

    Yao Wang, MD

    Not yet recruiting

  • Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University

    Zhuhai, Guangdong

    Hui Liang, BD, 086-13702760386, zhlianghui@126.com

    Hui Liang, BD

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Radical colectomy, HIPEC, Systemic chemotherapy
Keywords
Colorectal cancer, Colectomy, Hyperthermic intraperitoneal chemotherapy, Peritoneal carcinomatosis
Medical subject headings
Colorectal Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical colectomyProcedure or surgery

    Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)

  • HIPECProcedure or surgery

    HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.

  • Systemic chemotherapyDrug

    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.

Study groups in NCT04370925
Study groupRoleWhat they receive
Matched controlActive comparatorPatients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy
Receives: Procedure: Radical colectomy; Drug: Systemic chemotherapy
HIPECExperimentalPatients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy
Receives: Procedure: Radical colectomy; Procedure: HIPEC; Drug: Systemic chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-year

Secondary outcomes (4)

  1. 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.

    Measured: 3-year

  2. Overall survival

    Overall survival is calculated from randomization to death from any cause.

    Measured: 5-year

  3. Liver metastatic rate

    Liver metastatic rate is calculated from randomization to to the date of liver metastasis with or without other organ metastasis.

    Measured: 3-year

  4. Number of participants with adverse events

    Incidence of acute and late toxicity

    Measured: Up to 1 month after the last chemotherapy cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start4 Jun 2020
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
688 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04370925
Sponsor's protocol ID
HIPEC-06
Status last verified
Apr 2020
First submitted
8 Apr 2020
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radical colectomy, HIPEC and Systemic chemotherapy in people with Colorectal Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 37 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shuzhong Cui, MD (086-13802513800, cuishuzhong@gzhmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peritoneal recurrence free survival (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04370925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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