Condition: Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs) · Sponsor: Grupo Espanol de Tumores Neuroendocrinos
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.
This description comes directly from the study's public registry record.
A responsible person designated by the sponsor · +34 93 434 44 12 · investigacio@mfar.net
Responsible person designated by the sponsor · +34 93 434 44 12 · investigacion@mfar.net
Always discuss trial participation with your own doctor first.
| Centre François BACLESSE | Caen, Caen, France | Not Yet Recruiting |
| Chu Dijon | Dijon, Dijon, France | Not Yet Recruiting |
| Hospital Center University De Lille | Lille, Lille, France | Not Yet Recruiting |
| Hospices civiles de Lyon | Lyon, Lyon, France | Not Yet Recruiting |
| Institut Paoli Calmette | Marseille, Marseille, France | Not Yet Recruiting |
| Hopital BEAUJON | Clichy, Paris, France | Not Yet Recruiting |
| Hopital COCHIN | Paris, Paris, France | Not Yet Recruiting |
| Centre Eugène MARQUIS | Rennes, Rennes, France | Not Yet Recruiting |
| Hospital Universitario de Burgos | Burgos, Balearic Islands, Spain | Recruiting |
| Hospital Universitari Vall d'Hebrón | Barcelona, Barcelona, Spain | Recruiting |
| Instituto Catalán de Oncología - Hospital Duran i Reynals | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
| Hospital Virgen de las Nieves de Granada | Granada, Granada, Spain | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06878664