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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
Sponsor:
Information provided by (Responsible Party):

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


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 :
  1. 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

Information from the National Library of Medicine

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