Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Status:
RECRUITING
Trial end date:
2029-01-01
Target enrollment:
Participant gender:
Summary
This is a randomized Phase II/late phase I de-escalation clinical trial with approved investigational medicinal products in new use condition, low intervention.
Disease under study Patients with unresectable or metastatic, slowly progressive, well-differentiated (Grade1 and Grade2), somatostatin receptor-positive midgut neuroendocrine tumors (GEP-NETs).
It is planned to randomize 166 patients with a histologically confirmed diagnosis of slowly progressive grade 1 or grade 2 advanced midgut neuroendocrine tumors (NETs) candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT). Patients are required to have SSTR+ disease, as evidenced on somatostatin receptor imaging. Patients will be randomized into two arms:
1. control arm: regimen 177Lu-Dotatate every 8 weeks (q8w)
2. experimental arm: regimen 177Lu-Dotatate every 16 weeks (q16w)
Research hypothesis: Less intensive somatostatin-receptor (SST) targeted radioligand therapy (RLT) (7.4 GBq/cycle 177Lu-Dotatate every 16 weeks x 4 cycles) is associated with less severe hematological toxicities and may mitigate the risk to develop therapy-related myeloid neoplasms (t-MN) with similar antitumor efficacy in slowly growing gastrointestinal grade 1-2 NETs.
Phase:
PHASE3
Details
Lead Sponsor:
Grupo Espanol de Tumores Neuroendocrinos
Collaborator:
Grupo Espaol de Tumores Neuroendocrinos y Endocrinos (GETNE)
Treatments:
amino-acid, glucose, and electrolyte solution copper dotatate CU-64 lanreotide Lutetium lutetium Lu 177 dotatate Lutetium-177