Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver
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.
• Participants 18 years and older;
• Biopsy-proven neuroendocrine tumor.
• Measurable metastasis to liver with at least one dimension ≥ 1.0 cm.
• Tumor burden dominant in the liver AND liver tumor burden less than or equal to 70% of the total liver volume by visual estimate.
• Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
• Symptoms uncontrolled by somatostatin analogues OR morphologically progressive tumor by RECIST 1.1 criteria in the liver OR baseline tumor burden \>25% of the liver volume.
• There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than somatostatin analogs or bone-strengthening agents).
• Performance status 0-2 on Zubrod/ECOG Performance Scale;
• Serum creatinine \< 2.0 mg/dL;
• Serum Bilirubin ≤ 2.0 mg/dL
• Serum albumin ≥ 3.0 g/dL
• Platelet count \> 50 thousands/uL (corrected if needed)
• INR ≤ 1.5 (corrected if needed)
• All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry.