MedTrace Logo

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver

NCT02724540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-01-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Guerbet

    collaborator INDUSTRY

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Michael C Soulen, MD, FSIR · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2024-04-30
Completion
2024-11-08

Countries

  • United States
  • Argentina
  • Canada
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724540 on ClinicalTrials.gov