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

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ClinicalTrials.gov Identifier: NCT02082886
Recruitment Status : Recruiting
First Posted : March 10, 2014
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Peritoneal Neoplasms Neoplasm Metastasis Adenocarcinoma Sarcoma

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Primary Completion Date : January 2034
Estimated Study Completion Date : January 2034

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Kathy Seymour, BSN 630-646-6072 Kathy.Seymour@EEHealth.org

Locations
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United States, Illinois
Elmhurst Memorial Health Care Recruiting
Elmhurst, Illinois, United States, 60126
Contact: Kathy Seymour, BSN    630-646-6072    Kathy.Seymour@EEHealth.org   
Principal Investigator: George I Salti, MD         
Edward Hospital Recruiting
Naperville, Illinois, United States, 60540
Contact: Kathy Seymour, BSN    630-646-6072    Kathy.Seymour@EEHealth.org   
Principal Investigator: George I Salti, MD         
Sponsors and Collaborators
Edward-Elmhurst Health System
Investigators
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Principal Investigator: George I Salti, MD Edward-Elmhurst Healthcare

Additional Information:
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Responsible Party: Edward-Elmhurst Health System
ClinicalTrials.gov Identifier: NCT02082886     History of Changes
Other Study ID Numbers: EDW120613A
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Keywords provided by Edward-Elmhurst Health System:
Sarcomatosis
Metastasis
Carcinomatosis
Carcinosis
CRS
Cytoreductive surgery
HIPEC
Heated Intraperitoneal Chemotherapy
Intra-abdominal
Sugarbaker technique
Mitomycin C
Cisplatin
Doxorubicin
Oxaliplatin
Melphalan

Additional relevant MeSH terms:
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Neoplasms
Adenocarcinoma
Neoplasm Metastasis
Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases