NCT02724540

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

Conditions

• Neuroendocrine Tumor, Malignant
• Liver Metastases

Interventions

Type	Name	Description
DEVICE	Bland Embolization	Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
COMBINATION_PRODUCT	Transarterial chemoembolization	Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.
COMBINATION_PRODUCT	Drug Eluting Beads Embolization	CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.

Timeline

• Start date: 2016-03-01
• Primary completion: 2024-04-30
• Completion: 2024-11-08
• First posted: 2016-03-31
• Last updated: 2025-01-06

Locations

13 sites across 4 countries: United States, Argentina, Canada, Italy