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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082886
• Other study ID #: EDW120613A
• Status: Completed
• Start date: February 2014
• Est. completion date: January 2020

Study information

• Verified date: January 2020
• Source: Edward-Elmhurst Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Neoplasm Metastasis
• Neoplasms
• Peritoneal Neoplasms
• Sarcoma

Locations

Country	Name	City	State
United States	Elmhurst Memorial Health Care	Elmhurst	Illinois
United States	Edward Hospital	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Edward-Elmhurst Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	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	Progression-free survival rate	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
Secondary	Rates of complications	Collect data from patients to examine rates of complications in specific patient populations	During procedure until approximately 90 days post

External Links

•   Related Info