Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed (HIPEC)

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ClinicalTrials.gov Identifier: NCT01617382

Recruitment Status : Recruiting

First Posted : June 12, 2012

Last Update Posted : July 29, 2016

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Universitaire Ziekenhuizen Leuven

Study Description

Brief Summary:

The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.

Condition or disease
Peritoneal Carcinomatosis Pseudomyxoma Peritonei Peritoneal Mesothelioma

Detailed Description:

To register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC. In this surgical intervention, the abdominal cavity is macroscopically cleared of tumor, by removing all visible tumor nodules, and is subsequently rinsed with hyperthermic (heated) chemotherapy, aiming to destroy all residual invisible tumor cells that might have stayed behind after the debulking.

The eventual aim of this procedure is to improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.

Study Design


Study Type :	Observational
Estimated Enrollment :	125 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Register With Data From Patients With the Diagnosis of a Peritoneal Surface Malignancy, for Which Cytoreductive Surgery and Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) is Performed
Study Start Date :	May 2012
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma Pseudomyxoma Peritonei Gelatinous Ascites

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Registry Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy

Outcome Measures

Primary Outcome Measures :

To improve the prognosis/survival of patients with malignancies localized on the peritoneal surface. [ Time Frame: Follow-up over a time period of at least 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy.

Criteria

Inclusion Criteria:

Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy

Contacts and Locations

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): NCT01617382

Contacts


Contact: Isabelle B Terrasson	+32 16 340837	isabelle.terrasson@uzleuven.be

Locations


Belgium
University Clinics Gasthuisberg	Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Isabelle B Terrasson +32 16 340837 isabelle.terrasson@uzleuven.be
Contact: Daphne Hompes, MD +32 16 341826 daphne.hompes@uzleuven.be
Principal Investigator: André JL D'HOORE, PhD

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators


Principal Investigator:	André JL D'Hoore, PhD	University Clinics Gasthuisberg Department of Abdominal Surgery

More Information


Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01617382 History of Changes
Other Study ID Numbers:	S-54350
First Posted:	June 12, 2012 Key Record Dates
Last Update Posted:	July 29, 2016
Last Verified:	July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Universitaire Ziekenhuizen Leuven:


HIPEC Hyperthermic (heated) chemotherapy after debulking

Additional relevant MeSH terms:


Pseudomyxoma Peritonei Mesothelioma Carcinoma Fever Adenoma Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Body Temperature Changes Signs and Symptoms Neoplasms, Cystic, Mucinous, and Serous

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