Clinical trial NCT02082886: HIPEC For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
Official title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Neoplasms
Neoplasm Metastasis
Adenocarcinoma
Sarcoma
Keywords: Metastasis
Carcinomatosis
Carcinosis
Sarcomatosis
CRS
Cytoreductive surgery
HIPEC
Heated Intraperitoneal Chemotherapy
Intra-abdominal
Sugarbaker technique
Mitomycin C
Cisplatin
Doxorubicin
Oxaliplatin
Melphalan
Lead sponsor: Edward-Elmhurst Health System
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 193
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival rate
timeFrame: From time of treatment until death, approximately 10 years
Secondary outcomes:
measure: Progression-free survival rate
timeFrame: From time of treatment until time of disease progression, approximately 10 years
measure: Rates of complications
timeFrame: During procedure until approximately 90 days post
Other outcomes:
Locations:
city: Elmhurst
country: United States
facility: Elmhurst Memorial Health Care
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
Study officials:
affiliation: Edward-Elmhurst Healthcare
name: George I Salti, MD
role: PRINCIPAL_INVESTIGATOR
References: