ReLUTH (Phase II)

Investigator physician: Dr Elodie CHEVALIER

A prospective randomized phase ii study to assess the schemas of retreatment with lutathera® ([177Lu]lu-dota-tate) in patients with new progression of intestinal well-differentiated neuroendocrine tumor

intestinal well-differentiated neuroendocrine tumor

Prospective, nationwide, multicenter, open-label, randomized, Phase II study to compare two additional cycles of Lutathera® with active surveillance in patients who have already received two cycles of theragnostics (already treated with two cycles).
Patients previously treated with 4 cycles of Lutathera® will be enrolled after a first progression (clinical, biological and/or radiological) of their neuroendocrine tumor.
The first step is inclusion in sequence 1:
During this "sequence 1", all patients will receive 2 cycles of Lutathera®.
Radiological assessment of the tumor will be performed after these 2 cycles.
Patients showing progression during the first retreatment sequence will be considered as screening failures. They will be followed until the end of the study.

The second stage is randomization:
Patients with controlled disease will be randomized (1:1) to :
- Experimental arm: 2 cycles of Lutathera®.
- Control arm: No treatment (active surveillance)

Treatment: Lutathera ®
Study status: Recruiting
Clinical Trial number: NCT04954820