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Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
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Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
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Journal Article
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
2018
Overview
Background
Neuroendocrine tumors (NETs) are the second most common gastrointestinal malignancy after colon cancer. Up to 90% of patients with NETs develop liver metastases, which are a major determinant of symptoms and survival. Current guidelines recommend embolotherapy for progressive or symptomatic NET liver metastases, but the optimal technique among bland embolization, lipiodol chemoembolization, and drug-eluting bead chemoembolization remains unknown and controversial.
Methods/design
A prospective, open-label, multicenter randomized controlled trial will be conducted in patients with progressive or symptomatic unresectable NET liver metastases. Patients will be randomized to treatment with bland embolization, lipiodol chemoembolization, or drug-eluting microsphere chemoembolization, with 60 enrollees per arm. The primary endpoint will be hepatic progression-free survival (HPFS) following initial embolotherapy by RECIST criteria. The sample size is powered to detect an HR of 1.78 for HPFS following chemoembolization compared with bland embolization, which was estimated on the basis of existing retrospective studies. Secondary endpoints include overall progression-free survival, duration of symptom control, quality of life, rate of adverse events, and interval between embolotherapy cycles. Interim safety analyses will be performed at 10 and 30 patients per arm.
Discussion
The RETNET trial is a prospective, multicenter randomized controlled trial designed to determine the optimal embolotherapy technique for NET liver metastases.
Trial registration
ClinicalTrials.gov,
NCT02724540
. Registered on March 31, 2016.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Antibiotics, Antineoplastic - administration & dosage
/ Antibiotics, Antineoplastic - adverse effects
/ Biopsy
/ Canada
/ Chemoembolization, Therapeutic - adverse effects
/ Chemoembolization, Therapeutic - mortality
/ Consent
/ Doxorubicin - administration & dosage
/ Doxorubicin - adverse effects
/ Embolization, Therapeutic - adverse effects
/ Embolization, Therapeutic - mortality
/ Ethiodized Oil - administration & dosage
/ Ethiodized Oil - adverse effects
/ France
/ Humans
/ Liver
/ Liver Neoplasms - diagnostic imaging
/ Medicine
/ Multicenter Studies as Topic
/ Neuroendocrine Tumors - diagnostic imaging
/ Neuroendocrine Tumors - mortality
/ Neuroendocrine Tumors - secondary
/ Neuroendocrine Tumors - therapy
/ Patients
/ Randomized Controlled Trials as Topic
