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RECRUITING
NCT06057935
PHASE2

A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.

Official title: ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2023-09-21

Completion Date

2028-09-21

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

DRUG

Pemetrexed

Pemetrexed will be administered intravenously

DRUG

Cisplatin

Cisplatin will be administered intravenously

DRUG

Carboplatin

Possible substitution with carboplatin based on clinician discretion

Locations (13)

University of Chicago (Data Collection Only)

Chicago, Illinois, United States

University of Michigan (Data Collection Only)

Ann Arbor, Michigan, United States

Washington University (Data Collection Only)

St Louis, Missouri, United States

University of Nebraska (Data collection only)

Omaha, Nebraska, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Rutgers University (Data Collection Only)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activites)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Allegheny Health Network (Data Collection Only)

Pittsburgh, Pennsylvania, United States