Peritoneal MesotheliomasNCT01812148
Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
An observational study of Peritoneal Mesotheliomas, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Mesotheliomas
- What is being tested?
- Cytoreductive surgery and HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Mar 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC
Who may be able to join
- Peritoneal mesothelioma
Who cannot join
- Non resectable disease
Trial locations and contacts
1 site in 1 country.
About this study
Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.
Read the detailed description
Observation of primary outcome:
- Overall Survival
- Disease-free survival
Influencing factors that will be observe:
- Sex
- Blood loss
- Time of surgery
- Number of resection and anastomosis
- Peritoneal Index (PI score)
- Cytoreductibility (CCR score)
- Conditions
- Peritoneal Mesotheliomas
- Being tested
- Cytoreductive surgery and HIPEC
- Keywords
- Peritoneal Mesotheliomas, hyperthermic intra-peritoneal chemotherapy (HIPEC), Oxaliplatin, Cytoreductive surgery, Oxaliplatin HIPEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgery and HIPECProcedure or surgery
Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Mesotheliomas | Cytoreductive surgery and HIPEC Receives: Procedure: Cytoreductive surgery and HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (1)
Disease-Free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MesotheliomasStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Hubert, Maisonneuve-Rosemont Hospital
- Investigators
- Lucas Sideris, MD, Study director, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812148
- Sponsor's protocol ID
- Maisonneuve Rosemont Hospital
- Other IDs
- 12112
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
- ClinicalTrials.gov ID
- NCT01812148
- Acronym / sponsor ID
- Maisonneuve Rosemont Hospital
- Conditions
- Peritoneal Mesotheliomas
- Keywords
- Peritoneal Mesotheliomas, hyperthermic intra-peritoneal chemotherapy (HIPEC), Oxaliplatin, Cytoreductive surgery, Oxaliplatin HIPEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Mar 2013 (estimated)
- 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.
Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.
Detailed description
Observation of primary outcome:
- Overall Survival
- Disease-free survival
Influencing factors that will be observe:
- Sex
- Blood loss
- Time of surgery
- Number of resection and anastomosis
- Peritoneal Index (PI score)
- Cytoreductibility (CCR score)
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Mesotheliomas | – | Procedure: Cytoreductive surgery and HIPECCytoreductive surgery and HIPEC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC
Key inclusion criteria (1 listed)
- Peritoneal mesothelioma
Key exclusion criteria (1 listed)
- Non resectable disease
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 |
|---|---|---|
| Cytoreductive surgery and HIPECCytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent | Procedure or surgery | Peritoneal Mesotheliomas |
Primary outcome
Overall survival
Time frame: 5 years
1 secondary outcome
Disease-Free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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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.
Lucas Sideris, MD study director
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Mesotheliomas, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2013. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 5 years). 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 Mar 2013.