A Phase 2 Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

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Full Title

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

Purpose

Peritoneal mesothelioma is a cancer of the inner lining of the abdomen (belly). The people in this study will be having surgery to take out as much of the cancer as possible. They will also receive heated chemotherapy given directly into the abdomen to kill any remaining cancer cells.

Researchers think that giving even more chemotherapy may make the treatment work better against mesothelioma. They want to know if it’s better to give this extra chemotherapy directly into the belly or intravenously (by vein).

If you join this study, you will have surgery to remove your mesothelioma as well as the heated chemotherapy. Then you will be randomly assigned to one of two groups:

  • Getting the extra chemotherapy in the belly, or
  • Getting the extra chemotherapy intravenously.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have peritoneal mesothelioma that will be taken out with surgery.
  • Have not had prior treatment with abdominal chemotherapy or platinum-containing anti-cancer drugs.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Garrett Nash at 212-639-8668.

Protocol

23-145

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06057935