HIPEC For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
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|ClinicalTrials.gov Identifier: NCT02082886|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : January 29, 2020
|Condition or disease|
|Peritoneal Neoplasms Neoplasm Metastasis Adenocarcinoma Sarcoma|
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 [Patient Registry]|
|Actual Enrollment :||193 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082886
|United States, Illinois|
|Elmhurst Memorial Health Care|
|Elmhurst, Illinois, United States, 60126|
|Naperville, Illinois, United States, 60540|
|Principal Investigator:||George I Salti, MD||Edward-Elmhurst Healthcare|