Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial

Trials
James X ChenMichael C Soulen

Abstract

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. 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, a...Continue Reading

References

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Citations

Sep 13, 2020·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Xiao-Ru YangA Micheil Innes
Jul 8, 2020·Annals of Surgical Oncology·Alexandra Gangi, James R Howe
May 25, 2020·Current Treatment Options in Oncology·Donna D'SouzaShamar Young
Aug 17, 2020·Current Gastroenterology Reports·Mengyuan LiuRasa Zarnegar
Dec 18, 2020·Seminars in Interventional Radiology·Evan D Lehrman, Nicholas Fidelman
Mar 16, 2021·Current Oncology Reports·Ashley Kieran Clift, Andrea Frilling
Mar 17, 2020·Neuroendocrinology·Rahul KanabarAngela Lamarca

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Methods Mentioned

BETA
surgical resection
biopsy

Software Mentioned

ORACLE

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