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

Protocol No
U-PENN-UPCC-01215-RETNET
Principal Investigator
Sarah White
Phase
II
Summary
The purpose of this study is 1) to determine if one or more of the three techniques provide longer-lasting control of tumors in the liver, and 2) to see if outcomes for patients treated with the three techniques show that there are differences in quality of life, side effects, or safety. NET liver metastases respond well to embolization, which means injecting tiny particles with or without chemotherapy drugs into the arteries feeding the tumors to cut off their blood supply. This has been a standard treatment used for more than 30 years. National and international treatment guidelines recommend any of three different techniques for embolization of progressive or symptomatic liver metastases: 1) Bland embolization, in which tiny plastic beads are injected into the artery to the liver to cut off blood flow to the tumors; 2) Conventional TACE (transarterial chemoembolization), injecting an oily emulsion (mixture) of chemotherapy (doxorubicin) with the plastic beads; and 3) DEB-TACE (drug-eluting bead chemoembolization), in which a chemotherapy drug (doxorubicin) is directly loaded (absorbed) on the plastic beads which are used for the injection All three of these techniques are equally used in practice in the United States, and all have similarly good immediate results controlling tumors in the liver. Past experience at different centers suggests that one or more of these techniques might be more effective than others at delaying the time to progression of the tumor. For example, several centers report a trend toward longer time to tumor progression with chemoembolization, while other centers report no difference. Past experience also suggests that some techniques may be more likely to cause damage to the bile ducts than the others. However, these impressions are based on historical reports from individual institutions, with widely overlapping and sometimes contradictory results. The techniques of embolization have never been formally studied in scientifically rigorous clinical trial. This trial will be the first to investigate if there are real differences among the embolization techniques in effectiveness, safety, and/or quality of life. This research study is supported by money from Guerbet, LLC given to Michael C. Soulen, MD of the University of Pennsylvania to oversee and lead this research study overall. In addition, Dr. Soulen is the principal investigator for this study at the University of Pennsylvania. Sarah White, MD is the principal investigator of this study at the Medical College of Wisconsin.
Description
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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