Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas…). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administration of 4 cycles of therapy with 7.4 Gbq Dose for No risk factors Arm and 5.5 Gbq Dose for Risk Factor Arm. Both through slow intravenous infusion in 30 minutes with a dedicated pump system.
AUSL Romagna - Ospedale "M. Bufalini"
Cesena, Forlì-Cesena, Italy
NOT_YET_RECRUITINGIRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, Italy
RECRUITINGEfficacy as Disease control rate (DCR)
percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) at the 1st planned evaluation.
Time frame: 32 months
(Safety) percentage of patients who experience acute toxicity
evaluated according to version 5.0 CTC-AE (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE). Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months.
Time frame: 37 months
Progression free survival
Time from the start treatment date to the date of first observation of documented disease progression or death due to any cause.
Time frame: 44 months
Overall survival
Time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Time frame: 44 months
Quality of life
Evaluated through validated standardized data collection forms from the EORTC QLQ-C30 questionnaire.
Time frame: 32 months
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