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
ClinicalTrials.gov