RecruitingPhase 2NCT06057935

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

64 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

Malignant Mesothelioma Mesothelioma Mesothelioma, Malignant Peritoneal Mesothelioma Malignant Peritoneal Mesothelioma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether additional chemotherapy given after surgery (cytoreductive surgery to remove all visible tumor) improves survival in people with malignant peritoneal mesothelioma — a rare cancer affecting the lining of the abdomen, often linked to asbestos exposure. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of epithelioid malignant peritoneal mesothelioma - You have undergone or are planning to undergo complete cytoreductive surgery (removal of all visible cancer from the abdomen) - Your ECOG performance status is 0 or 1 (generally healthy and active) - Your blood counts and organ function (kidneys, liver) meet the required thresholds **You may NOT be eligible if...** - Your mesothelioma is not the epithelioid type - Your tumor could not be fully removed during surgery - You are pregnant or breastfeeding - You have significant other health conditions that would make chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPemetrexed

Pemetrexed will be administered intravenously

DRUGCisplatin

Cisplatin will be administered intravenously

DRUGCarboplatin

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06057935

Related Trials

Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome

NCT044310241 location

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

NCT065031461 location

Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies

NCT048470631 location

Agnostic Therapy in Rare Solid Tumors

NCT066389318 locations

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

NCT019505721 location