- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01812148
Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
March 15, 2013 updated by: Julien Hubert, Maisonneuve-Rosemont Hospital
Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T 2M4
- Maisonneuve Rosemont Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC
Description
Inclusion Criteria:
- Peritoneal mesothelioma
Exclusion Criteria:
- Non resectable disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Peritoneal Mesotheliomas
Cytoreductive surgery and HIPEC
|
Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disease-Free survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lucas Sideris, MD, Maisonneuve-Rosemont Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 12, 2013
First Submitted That Met QC Criteria
March 15, 2013
First Posted (Estimate)
March 18, 2013
Study Record Updates
Last Update Posted (Estimate)
March 18, 2013
Last Update Submitted That Met QC Criteria
March 15, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Body Temperature Changes
- Heat Stress Disorders
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Hyperthermia
- Fever
- Mesothelioma
- Mesothelioma, Malignant
Other Study ID Numbers
- Maisonneuve Rosemont Hospital
- 12112 (Research Ethic committee of Maisonneuve Rosemont Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.