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Completed

NCT Number: NCT02082886

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Edward-Elmhurst Health System

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2014
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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