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Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed (HIPEC)
This study is currently recruiting participants.
Verified July 2016 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01617382
First received: June 8, 2012
Last updated: July 28, 2016
Last verified: July 2016
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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:
MedlinePlus related topics:
Fever
Genetic and Rare Diseases Information Center resources:
Malignant Mesothelioma
Pseudomyxoma Peritonei
Gelatinous Ascites
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 ]
| Estimated Enrollment: | 125 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2018 (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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617382
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
| 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: | July 28, 2016 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017