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

This study is currently recruiting participants.
Verified March 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01617382
First received: June 8, 2012
Last updated: February 19, 2013
Last verified: March 2012
History of Changes
  Purpose

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
Peritoneal Carcinomatosis
Pseudomyxoma Peritonei
Peritoneal Mesothelioma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: May 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01617382     History of Changes
Other Study ID Numbers: S-54350
Study First Received: June 8, 2012
Last Updated: February 19, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
HIPEC
Hyperthermic (heated) chemotherapy after debulking

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

ClinicalTrials.gov processed this record on May 22, 2013