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

• Sponsor: Maisonneuve-Rosemont Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01812148
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	Phase
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)

Study Design

• 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: Jan 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Overall survival [5 years]

Secondary Outcome Measures

1. Disease-Free survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Peritoneal mesothelioma

Exclusion Criteria:

• Non resectable disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maisonneuve Rosemont Hospital	Montréal	Quebec	Canada	H1T 2M4

Sponsors and Collaborators

• Maisonneuve-Rosemont Hospital

Investigators

• Study Director: Lucas Sideris, MD, Maisonneuve-Rosemont Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julien Hubert, Dr, Maisonneuve-Rosemont Hospital
• ClinicalTrials.gov Identifier: NCT01812148
• Other Study ID Numbers: Maisonneuve Rosemont Hospital; 12112
• First Posted: Mar 18, 2013
• Last Update Posted: Mar 18, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Julien Hubert, Dr, Maisonneuve-Rosemont Hospital: Peritoneal Mesotheliomas; hyperthermic intra-peritoneal chemotherapy (HIPEC); Oxaliplatin; Cytoreductive surgery; Oxaliplatin HIPEC
• Additional relevant MeSH terms: Mesothelioma; Mesothelioma, Malignant; Hyperthermia; Fever

Study Results

No Results Posted as of Mar 18, 2013