- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617382
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed (HIPEC)
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 Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Isabelle B Terrasson
- Phone Number: +32 16 340837
- Email: isabelle.terrasson@uzleuven.be
Study Locations
-
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Flemish Brabant
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Leuven, Flemish Brabant, Belgium, 3000
- Recruiting
- University Clinics Gasthuisberg
-
Contact:
- Isabelle B Terrasson
- Phone Number: +32 16 340837
- Email: isabelle.terrasson@uzleuven.be
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Contact:
- Daphne Hompes, MD
- Phone Number: +32 16 341826
- Email: daphne.hompes@uzleuven.be
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Principal Investigator:
- André JL D'HOORE, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Follow-up over a time period of at least 5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: André JL D'Hoore, PhD, University Clinics Gasthuisberg Department of Abdominal Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Peritoneal Diseases
- Neoplasms, Cystic, Mucinous, and Serous
- Abdominal Neoplasms
- Body Temperature Changes
- Adenocarcinoma, Mucinous
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Peritoneal Neoplasms
- Fever
- Pseudomyxoma Peritonei
Other Study ID Numbers
- S-54350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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