A Prospective Randomized Phase II Study to Assess Retreatment With Lutathera4 ([177Lu]Lu-DOTA-TATE) in Patients With New Progression of Intestinal Well-Differentiated Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the use of two additional cycles of Lutathera4 (a type of peptide receptor radionuclide therapy) compared to active surveillance in patients with intestinal well-differentiated neuroendocrine tumors (NETs) who have shown new disease progression after previous treatments. This study responds to varying clinical practices in France regarding retreatment cycles and aims to assess if additional Lutathera4 cycles can provide benefit in this setting. The trial is a randomized phase II study sponsored by the Institut du Cancer de Montpellier - Val d'Aurelle. Participants are randomly assigned to receive either two more infusions of Lutathera4 spaced eight weeks apart according to approved guidelines or to undergo active monitoring without additional treatment. Active surveillance involves clinical, biological, and radiological follow-up every two months. This design allows comparison between retreatment and observation in patients who have already received four initial cycles and two retreatment cycles previously. During the study, patients will be closely monitored through clinical exams, imaging tests such as CT or MRI scans, and laboratory tests at regular intervals. Researchers will assess the treatment's effectiveness by measuring disease progression every eight weeks over six months, as well as safety, progression-free survival, overall survival, and quality of life during treatment and for up to five years. Monitoring will ensure participant safety and collect data on long-term outcomes over several years, with scheduled assessments continuing for four years after treatment completion.

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