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Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01812148
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
Julien Hubert, Maisonneuve-Rosemont Hospital

Brief 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.

Condition or disease Intervention/treatment
Peritoneal Mesotheliomas Procedure: Cytoreductive surgery and HIPEC

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)

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Mesothelioma

Group/Cohort Intervention/treatment
Peritoneal Mesotheliomas
Cytoreductive surgery and HIPEC
Procedure: Cytoreductive surgery and HIPEC
Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease-Free survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC
Criteria

Inclusion Criteria:

  • Peritoneal mesothelioma

Exclusion Criteria:

  • Non resectable disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812148


Locations
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Canada, Quebec
Maisonneuve Rosemont Hospital
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Study Director: Lucas Sideris, MD Maisonneuve-Rosemont Hospital

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Responsible Party: Julien Hubert, Dr, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01812148    
Other Study ID Numbers: Maisonneuve Rosemont Hospital
12112 ( Registry Identifier: Research Ethic committee of Maisonneuve Rosemont Hospital )
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013
Keywords provided by Julien Hubert, Maisonneuve-Rosemont Hospital:
Peritoneal Mesotheliomas
hyperthermic intra-peritoneal chemotherapy (HIPEC)
Oxaliplatin
Cytoreductive surgery
Oxaliplatin HIPEC
Additional relevant MeSH terms:
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Mesothelioma
Fever
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Body Temperature Changes
Signs and Symptoms