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

NCT02082886 | Completed

• 1 other identifier: EDW120613A
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival rate

  From time of treatment until time of disease progression, approximately 10 years

• Rates of complications

  During procedure until approximately 90 days post

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital
• Provides consent by signing informed consent form

You may not qualify if:

• Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as determined by the PI
• Does not consent to participate

Sponsors & Collaborators

• Edward-Elmhurst Health System: lead

Study Sites (2)

Elmhurst Memorial Health Care

Elmhurst, Illinois, 60126, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Peritoneal Neoplasms; Neoplasm Metastasis; Adenocarcinoma; Sarcoma; Carcinoma

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue

Study Officials

• George I Salti, MD

  Edward-Elmhurst Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 10, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

US (2)