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.
Age ≥ 18 years,
Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),
Patient previously treated with 4 cycles of Lutathera® (defined as "First PRRT"),
Disease control after "First PRRT" ≥ 12 months,
Patient who did not respond (no CR, PR or SD) to "first PRRT".
Radiological progression after two cycles of "Second PRRT" according to RECIST version 1.1,
Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,
Pancreatic NET,
Institut du Cancer de Montpellier - Val d'Aurelle
Lead sponsor