At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Histologically confirmed intestinal G1 or G2 neuroendocrine tumors
- ✓Prior treatment with 4 cycles of Lutathera (first PRRT)
- ✓Disease control for at least 12 months after first PRRT
- ✕No response (no CR, PR, or SD) to first PRRT
- ✕Radiological progression after two cycles of second PRRT per RECIST 1.1
- ✕Grade 4 hematotoxicity and/or nephrotoxicity during initial PRRT, or unresolved Grade 2+ AEs from prior PRRT/therapy (except alopecia, peripheral neuropathy)
- ✕Pancreatic NET
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor
In Brief
A Phase 2 clinical trial evaluating Lutathera for Neuroendocrine Tumors and 2 related conditions. Currently recruiting, targeting 146 participants across 28 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
2 additional infusions of Lutathera®