Clinical Trial

Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET

Study acronym: ReLUTH
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2031-10 -> 2033-10 2026-06-05
minor Completion pushed: 2031-10 -> 2033-10 2026-06-05
Trial Details
NCT Number NCT04954820
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions Neuroendocrine Tumors, Intestinal Well Differentiated Endocrine Tumor, Progressive Disease
Enrollment 146 participants
Start Date 2021-10-18
Primary Completion 2033-10 (estimated)
Study Completion 2033-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-04