Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors

Recruiting Phase 3 Interventional Study
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
166 (estimated)
Sponsor
Grupo Espanol de Tumores Neuroendocrinos · Other
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients who have histologically confirmed diagnosis of unresectable, advanced or metastatic midgut NETs (originated in the jejunum-ileum or right colon) who are candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT) and SSA. Patients with a large SRI+ mesent…
Contacts

A responsible person designated by the sponsor

+34 93 434 44 12

investigacio@mfar.net

CONTACT

Responsible person designated by the sponsor

+34 93 434 44 12

investigacion@mfar.net

CONTACT