NCT01617382

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
May 2012Dec 2028

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

16.6 years

First QC Date

June 8, 2012

Last Update Submit

June 25, 2024

Conditions

Keywords

HIPECHyperthermic (heated) chemotherapy after debulking

Outcome Measures

Primary Outcomes (1)

  • To improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.

    Follow-up over a time period of at least 5 years

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinics Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Peritoneal NeoplasmsPseudomyxoma PeritoneiFever

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesAdenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Cystic, Mucinous, and SerousBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • André JL D'Hoore, PhD

    University Clinics Gasthuisberg Department of Abdominal Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations