Peritoneal Metastases From Colorectal CancerNCT03398512
HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
A study testing exploratory laparoscopy or laparotomy, HIPEC and Systemic chemotherapy in people with Peritoneal Metastases From Colorectal Cancer, run by Wuhan University at 1 site in China.
Trial summary
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Metastases From Colorectal Cancer
- What is being tested?
- exploratory laparoscopy or laparotomy, HIPEC and Systemic chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 20 Mar 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proved diagnosis of colorectal cancer.
- Unresectable peritoneal metastases and primary tumor proved at surgery.
- No evidence of distant metastases.
- Have not received radiotherapy, chemotherapy or immunotherapy.
- ECOG score: 0~2.
- Written informed consent is obtained prior to commencement of trial treatment.
Who cannot join
- Existence of distant metastasis outside the abdomen.
- Any previous radiotherapy, chemotherapy or immunotherapy.
- Active systemic infections.
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.
Read the detailed description
To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
- Being tested
- exploratory laparoscopy or laparotomy, HIPEC, Systemic chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exploratory laparoscopy or laparotomyProcedure or surgery
Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
HIPECProcedure or surgery
Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.
Systemic chemotherapyDrug
Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy. Receives: Procedure: exploratory laparoscopy or laparotomy; Procedure: HIPEC; Drug: Systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
radical resection rate
The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
Measured: 3 months
Secondary outcomes (3)
the Peritoneal Cancer Index score
The score range from 0 to 39, higher values represent a worse outcome
Measured: 3 months
overall survival
The overall survival time
Measured: 3 years
complication rate
The rate of adverse complication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Feb 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: No enrolled patients received the second surgery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Metastases From Colorectal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Xiong, MD, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398512
- Sponsor's protocol ID
- WuhanU_Peritoneal M_colon
- Status last verified
- Mar 2020
- First submitted
- 4 Jan 2018
- Last updated
- 24 Mar 2020
- 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03398512
- Acronym / sponsor ID
- WuhanU_Peritoneal M_colon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enrolled patients received the second surgery.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 12 Jan 2018 (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.
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.
Detailed description
To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: exploratory laparoscopy or laparotomy, Procedure: HIPEC, Drug: Systemic chemotherapyHIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological proved diagnosis of colorectal cancer.
- Unresectable peritoneal metastases and primary tumor proved at surgery.
- No evidence of distant metastases.
- Have not received radiotherapy, chemotherapy or immunotherapy.
- ECOG score: 0~2.
Key exclusion criteria (5 listed)
- Existence of distant metastasis outside the abdomen.
- Any previous radiotherapy, chemotherapy or immunotherapy.
- Active systemic infections.
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
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 |
|---|---|---|
| exploratory laparoscopy or laparotomyExploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery | Procedure or surgery | Experimental |
| HIPECNormal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min. | Procedure or surgery | Experimental |
| Systemic chemotherapyOxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week | Drug | Experimental |
Primary outcome
radical resection rate
Time frame: 3 months
The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
3 secondary outcomes
the Peritoneal Cancer Index score
Time frame: 3 months
overall survival
Time frame: 3 years
complication rate
Time frame: 3 years
Results and safety
The study was stopped early (reason given: No enrolled patients received the second surgery.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exploratory laparoscopy or laparotomy, HIPEC and Systemic chemotherapy in people with Peritoneal Metastases From Colorectal Cancer, run by Wuhan University at 1 site 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: No enrolled patients received the second surgery.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radical resection rate (time frame: 3 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 24 Mar 2020.