Overview

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

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators:

Advanced Accelerator Applications
National Cancer Institute, France

Treatments:

Lutetium Lu 177 dotatate
Sunitinib