Colorectal NeoplasmsPhase 3NCT03221608
Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
A Phase 3 study testing Surgery and HIPEC with Lobaplatin and Surgery without HIPEC in people with Colorectal Neoplasms, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Surgery and HIPEC with Lobaplatin and Surgery without HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Aug 2024
- 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
- Histologically-proven colorectal adenocarcinoma
- Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
- Signed informed consent
- White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
- No bleeding diathesis or coagulopathy
- Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial
Who cannot join
- Liver and/or lung metastases
- Pregnant women or likely to be pregnant
- Severe hepatic and / or renal dysfunction
- Impossibility of an adequate follow-up
- Without history of cancer during last 5 years
- Other concurrent chemotherapy
- Severe or uncontrolled mental illness
- Patients with epilepsy required to be treated
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery: A Multicentre Randomised Clinical Trial
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.
Read the detailed description
Background:
Colorectal cancer (CRC) is the third most common malignancy worldwide, nearly 1.4 million new cases every year, for about 694000 deaths. Surgery is the primary treatment and results in a cure rate of approximately 50% of the patients. However, recurrence following surgery is a major problem, the second most common site of recurrence was peritoneum, which was as a result of the intraperitioneal free cancer cells (FCC) and microscopic cancer (MC). The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the "peritoneal-plasma barrier" and "non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy". In recent years, hyperthermic intraperitioneal chemotherapy(HIPEC) has already been shown to be effective in improving the 5 year survival rate of colorectal cancer. However, lots of clinically studies for patients with colorectal cancer are advanced, it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer. The efficacy tend to be magnified when stage T4 patients account for less, confusing HIPEC for treatment of patients with advanced colorectal cancer. Therefore, the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients, ruling out the effects of different T stages on curative effect. The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer.
Study design： This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone (control group) or HIPEC (experimental group) after resection of the primary tumor, either by laparoscopy or open approach. Subsequently, all patients started mfolfox6 chemotherapy after operation in a month. Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded.
Study population:
The patients with colorectal cancer (T4N0-2M0) will undergo a curative resection by laparoscopy or open approach.
Intervention:
HIPEC equipment used in the perfusion fluid (Lobaplatin of 50mg completely dissolved in 3000ml saline solution) is headed to 43℃. Then, it is injected into the peritoneal cavity by flow velocity of 200-400ml/min for 60 minutes.
Outcomes:
Primary endpoint is incidence of endoperitoneal recurrence at 36 months. Secondary endpoints are disease-free survival, overall survival, incidence of peritoneal carcinomatosis at end of follow-up with or without concomitant liver/lung metastases, quality of life and morbidity rate.
- Conditions
- Colorectal Neoplasms
- Being tested
- Surgery and HIPEC with Lobaplatin, Surgery without HIPEC
- Keywords
- Colorectal Cancer, HIPEC, Peritoneal Carcinomatosis, Lobaplatin
- 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.
Surgery and HIPEC with LobaplatinProcedure or surgery
Also called The combination of surgery and HIPEC with Lobaplatin
The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).
Surgery without HIPECProcedure or surgery
Also called Standard surgical treatment by laparoscopy or open approach.
The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.
| Study group | Role | What they receive |
|---|---|---|
| surgery alone(open/laparoscopic) | Active comparator | The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic). Receives: Procedure: Surgery without HIPEC |
| surgery and HIPEC | Experimental | Standard surgical treatment and HIPEC with Lobaplatin. Receives: Procedure: Surgery and HIPEC with Lobaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of endoperitoneal recurrence at 36 months
Measured: 36 months
Secondary outcomes (7)
Disease-free survival (DFS)
Measured: 3 years
Disease-free survival (DFS)
Measured: 5 years
Overall survival (OS)
Measured: 3 years
Overall survival (OS)
Measured: 5 years
Quality of life
To evaluate quality of life with EORTC QLQ-30 questionnaire
Measured: 3 years
HIPEC toxicity rate
Measured: 1 month
HIPEC toxicity rate
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, First Affiliated Hospital of Jinan University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou General Hospital of Guangzhou Military Command, Tcm-integrated Cancer Center of Southern Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Donglin Ren, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- MeiJin Huang, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221608
- Sponsor's protocol ID
- zs6yhmjHIPEC2017
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery: A Multicentre Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03221608
- Acronym / sponsor ID
- zs6yhmjHIPEC2017
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Cancer, HIPEC, Peritoneal Carcinomatosis, Lobaplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, First Affiliated Hospital of Jinan University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou General Hospital of Guangzhou Military Command, Tcm-integrated Cancer Center of Southern Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.
Detailed description
Background:
Colorectal cancer (CRC) is the third most common malignancy worldwide, nearly 1.4 million new cases every year, for about 694000 deaths. Surgery is the primary treatment and results in a cure rate of approximately 50% of the patients. However, recurrence following surgery is a major problem, the second most common site of recurrence was peritoneum, which was as a result of the intraperitioneal free cancer cells (FCC) and microscopic cancer (MC). The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the "peritoneal-plasma barrier" and "non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy". In recent years, hyperthermic intraperitioneal chemotherapy(HIPEC) has already been shown to be effective in improving the 5 year survival rate of colorectal cancer. However, lots of clinically studies for patients with colorectal cancer are advanced, it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer. The efficacy tend to be magnified when stage T4 patients account for less, confusing HIPEC for treatment of patients with advanced colorectal cancer. Therefore, the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients, ruling out the effects of different T stages on curative effect. The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer.
Study design： This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone (control group) or HIPEC (experimental group) after resection of the primary tumor, either by laparoscopy or open approach. Subsequently, all patients started mfolfox6 chemotherapy after operation in a month. Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded.
Study population:
The patients with colorectal cancer (T4N0-2M0) will undergo a curative resection by laparoscopy or open approach.
Intervention:
HIPEC equipment used in the perfusion fluid (Lobaplatin of 50mg completely dissolved in 3000ml saline solution) is headed to 43℃. Then, it is injected into the peritoneal cavity by flow velocity of 200-400ml/min for 60 minutes.
Outcomes:
Primary endpoint is incidence of endoperitoneal recurrence at 36 months. Secondary endpoints are disease-free survival, overall survival, incidence of peritoneal carcinomatosis at end of follow-up with or without concomitant liver/lung metastases, quality of life and morbidity rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery alone(open/laparoscopic) | Active comparator | Procedure: Surgery without HIPECThe patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic). |
| surgery and HIPEC | Experimental | Procedure: Surgery and HIPEC with LobaplatinStandard surgical treatment and HIPEC with Lobaplatin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically-proven colorectal adenocarcinoma
- Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
- Signed informed consent
- White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
- No bleeding diathesis or coagulopathy
Key exclusion criteria (8 listed)
- Liver and/or lung metastases
- Pregnant women or likely to be pregnant
- Severe hepatic and / or renal dysfunction
- Impossibility of an adequate follow-up
- Without history of cancer during last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery and HIPEC with LobaplatinAlso: The combination of surgery and HIPEC with LobaplatinThe combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0). | Procedure or surgery | surgery and HIPEC |
| Surgery without HIPECAlso: Standard surgical treatment by laparoscopy or open approach.The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach. | Procedure or surgery | surgery alone(open/laparoscopic) |
Primary outcome
Incidence of endoperitoneal recurrence at 36 months
Time frame: 36 months
7 secondary outcomes
Disease-free survival (DFS)
Time frame: 3 years
Disease-free survival (DFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 3 years
Overall survival (OS)
Time frame: 5 years
Quality of life
Time frame: 3 years
HIPEC toxicity rate
Time frame: 1 month
HIPEC toxicity rate
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MeiJin Huang, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery and HIPEC with Lobaplatin and Surgery without HIPEC in people with Colorectal Neoplasms, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 6 inclusion and 8 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 MeiJin Huang, MD (86-020-38250745, meijinhuang3@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of endoperitoneal recurrence at 36 months (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2017.