Peritoneal NeoplasmsNCT02082886
HIPEC For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
An observational study of Peritoneal Neoplasms and Neoplasm Metastasis, run by Edward-Elmhurst Health System at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Neoplasms, Neoplasm Metastasis, Adenocarcinoma
- How many people
- 193 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Jan 2020
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital
- Provides consent by signing informed consent form
Who cannot join
- Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as determined by the PI
- Does not consent to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elmhurst Memorial Health Care
Elmhurst, Illinois, 60126
Edward Hospital
Naperville, Illinois, 60540
About this study
Official title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
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.
Read the 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.
- 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
- Medical subject headings
- Peritoneal Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Sarcoma, Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Collect data from patients undergoing CRS/HIPEC which will be used to examine overall survival rates in specific patient populations.
Measured: From time of treatment until death, approximately 10 years
Secondary outcomes (2)
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
Measured: From time of treatment until time of disease progression, approximately 10 years
Rates of complications
Collect data from patients to examine rates of complications in specific patient populations
Measured: During procedure until approximately 90 days post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Edward-Elmhurst Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George I Salti, MD, Principal investigator, Edward-Elmhurst Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082886
- Sponsor's protocol ID
- EDW120613A
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2014
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry
- ClinicalTrials.gov ID
- NCT02082886
- Acronym / sponsor ID
- EDW120613A
- Conditions
- Peritoneal Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Sarcoma
- Keywords
- Metastasis, Carcinomatosis, Carcinosis, Sarcomatosis, CRS, Cytoreductive surgery, HIPEC, Heated Intraperitoneal Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Edward-Elmhurst Health SystemUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital
- Provides consent by signing informed consent form
Key exclusion criteria (2 listed)
- Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as determined by the PI
- Does not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Progression-free survival rate
Time frame: From time of treatment until time of disease progression, approximately 10 years
Rates of complications
Time frame: During procedure until approximately 90 days post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George I Salti, MD principal investigator
Edward-Elmhurst Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Neoplasms and Neoplasm Metastasis, run by Edward-Elmhurst Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: From time of treatment until death, approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 3 Nov 2026.