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

Completed

• Conditions: Adenocarcinoma; Sarcoma; Peritoneal Neoplasms; Neoplasm Metastasis

• Registration Number: NCT02082886
• Lead Sponsor: Edward-Elmhurst Health System

Brief Summary

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.

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival rate	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 Outcome Measures

Name	Time	Method
Rates of complications	During procedure until approximately 90 days post	Collect data from patients to examine rates of complications in specific patient populations
Progression-free survival rate	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

Trial Locations

Locations (2)

Elmhurst Memorial Health Care; 🇺🇸 Elmhurst, Illinois, United States

Edward Hospital; 🇺🇸 Naperville, Illinois, United States