Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II

Summary

This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.

Timeline

Start

2015-02

Primary completion

2024-04

Completion

2024-04

Publications

• Baudin E, Durand A, Beron A, Smith D, Deandreis D, Taieb D, Ansquer C, Dierickx L, Deshayes E, Hentic O, Moalla S, Menu Y, Lebtahi R, Assenat E, Touchefeu Y, Guimbaud R, Dahan L, Lamartina L, Cheurfa N, Quak E, Bouhier-Leporrier K, Haissaguerre M, Hindie E, Cao CD, Lombard-Bohas C, Jannin A, Walter T, Ducreux M, Chaib S, Hadoux J, Foulon S. [177Lu]Lu-dota-tate versus sunitinib in patients with metastatic progressive neuroendocrine tumours of the pancreas (OCLURANDOM): a randomised, controlled, phase 2 trial. Lancet Oncol. 2026 Jun;27(6):699-710. doi: 10.1016/S1470-2045(26)00108-7.

Drugs

Indications