Survival of Peritoneal Mesothelioma After Cytoreductive S... | NCT01812148

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

NCT01812148

Sponsor

Maisonneuve-Rosemont Hospital

Status

Completed

Last Update Posted

Mar 18, 2013Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Peritoneal Mesotheliomas

Interventions

Cytoreductive surgery and HIPEC

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12112	Registry Identifier	Research Ethic committee of Maisonneuve Rosemont Hospital

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 12, 2013

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peritoneal Mesotheliomas		Cytoreductive surgery and HIPEC	Procedure: Cytoreductive surgery and HIPEC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytoreductive surgery and HIPEC	Procedure	Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent	Peritoneal Mesotheliomas

Measure	Description	Time Frame
Overall survival		5 years

Measure	Description	Time Frame
Disease-Free survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Peritoneal mesothelioma

Exclusion Criteria:

Non resectable disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucas Sideris, MD	Maisonneuve-Rosemont Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maisonneuve Rosemont Hospital		Montreal	Quebec	H1T 2M4	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D065426	Cytoreduction Surgical Procedures
D000084262	Hyperthermic Intraperitoneal Chemotherapy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics

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Browse Branches

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