HIPEC For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry

January 27, 2020 updated by: Edward-Elmhurst Health System

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry

In this registry study the investigators will collect data about patients' disease, treatment, and response to treatment to include in both our local and national databases. These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC such as how well-tolerated or effective it is in specific populations.

Study Overview

Status

Completed

Conditions

Detailed Description

Patient Selection: The sole inclusion criteria for this study will be those consenting patients who are to undergo cytoreductive surgery followed by HIPEC.

Data Collection and Use Plan: For those patients who provide informed consent, data listed below will be collected during and after treatment. This will be entered into the PI's local database for future use and, after being de-identified, will be shared with a national database (held by the American Society of Peritoneal Surface Malignancies) to bolster the amount available for researchers looking at efficacy and outcomes such as overall survival rates, progression-free survival, and tolerability in certain populations.

Data Collected (as applicable): Age, primary tumor, dates of prior surgeries, prior chemotherapy with dates and whether it was neoadjuvant in nature, length of disease status, comorbidities, Peritoneal Surface Disease Severity Score, Peritoneal Cancer Index as determined prior to surgery, Peritoneal Cancer Index as determined during surgery, Completeness of Cytoreduction score, ascites present, blood products used, complications, length of stay in ICU and in hospital, where discharged, death within 30 days, readmission and reason, date of recurrence, treatment of recurrence, and time from procedure to death. For the HIPEC surgical procedure itself, data collected will be: date, duration, chemotherapeutic used and dose, duration of circulation, fluid temp, and flow rate.

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Health Care
      • Naperville, Illinois, United States, 60540
        • Edward Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The sole inclusion criteria for this study will be those consenting patients who are to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital.

Description

Inclusion Criteria:

  • Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital
  • Provides consent by signing informed consent form

Exclusion Criteria:

  • Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as determined by the PI
  • Does not consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: From time of treatment until death, approximately 10 years
Collect data from patients undergoing CRS/HIPEC which will be used to examine overall survival rates in specific patient populations.
From time of treatment until death, approximately 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate
Time Frame: From time of treatment until time of disease progression, approximately 10 years
Collect data from patients undergoing CRS/HIPEC which will be used to examine progression-free survival rates in specific patient populations
From time of treatment until time of disease progression, approximately 10 years
Rates of complications
Time Frame: During procedure until approximately 90 days post
Collect data from patients to examine rates of complications in specific patient populations
During procedure until approximately 90 days post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward-Elmhurst Health System

Investigators

  • Principal Investigator: George I Salti, MD, Edward-Elmhurst Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDW120613A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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