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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Lutathera

Treatment groups

146 Participants
are divided into 2 treatment groups