A Phase II Study of Different Embolization Approaches to Treat Neuroendocrine Liver Metastases

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Full Title

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver (RETNET): A Phase 2 Randomized Multicenter Trial to Compare Hepatic Progression-free Survival Following Bland Embolization, Lipiodol Chemoembolization, and Drug-eluting Bead Chemoembolization of Neuroendocrine Liver Metastases

Purpose

Neuroendocrine tumors that have spread to the liver (metastases) respond well to liver embolization treatment. Liver embolization works by cutting off the blood supply to tumors. Tiny particles (given with or without chemotherapy) are injected into the arteries that feed the tumors.

The purpose of this study is to determine which liver embolization technique provides longer-lasting control of tumors in the liver, and to see if there are differences in patients’ quality of life, side effects, or safety. Patients will be randomly assigned to one of these two embolization approaches:

  • “Bland” embolization, where tiny plastic beads are injected into the artery to cut off blood flow to tumors, or
  • Conventional “TACE” (transarterial chemoembolization), where tiny plastic beads plus chemotherapy (doxorubicin) are injected into the artery.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable metastatic neuroendocrine tumors in the liver.
  • Patients may not have received prior hepatic arterial therapy or hepatic radiation therapy. At least 1 month must pass between the completion of other prior treatments and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Etay Ziv at 212-639-3312.

Protocol

19-125

Phase

II

Investigator

Co-Investigators