"Receptor Radionuclide Therapy With 177Lu-DOTATOC

Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study ID
NCT06045260
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-DOTATOC — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 21, 2023
Start date
Sep 13, 2023
Status verified
Aug 2024
Primary completion
Feb 28, 2025
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 7.4 Gbq Dose
    Patients with less than 2 risk factors out of the following will receive a dose equal to 7.4 GBq of the experimental radiopharmaceutical 177Lutetium-DOTATOC: * Pre-existing renal impairment (Creatinine \> 1.5 mg/dl and/or eGFR or creatinine clearance \>50 and \< 60 ml/min) or(chemotherapy, local external radiotherapy); * Patients who have received earlier nephrotoxic treatment modalities (chemotherapy, local external field radiation); * Relevant renal morphological abnormalities; * Previously major (G3-4) iatrogenic toxicities; * ECOG = 2; * Any previous Peptide Receptor Radionuclide Therapy; * Type 1 or 2 diabetes not controlled with therapy; * Arterial hypertension not controlled with therapy; * Extension of disease = 4 according to "tumor burden Krenning scale" (9); * Age (\>80 years).
  • Experimental: 5.5 Gbq Dose
    Patients with al least 2 risk factors out of the following will receive a dose equal to 5.5 GBq of the experimental radiopharmaceutical 177Lutetium-DOTATOC: * Pre-existing renal impairment (Creatinine \> 1.5 mg/dl and/or eGFR or creatinine clearance \>50 and \< 60 ml/min) or(chemotherapy, local external radiotherapy); * Patients who have received earlier nephrotoxic treatment modalities (chemotherapy, local external field radiation); * Relevant renal morphological abnormalities; * Previously major (G3-4) iatrogenic toxicities; * ECOG = 2; * Any previous Peptide Receptor Radionuclide Therapy; * Type 1 or 2 diabetes not controlled with therapy; * Arterial hypertension not controlled with therapy; * Extension of disease = 4 according to "tumor burden Krenning scale" (9); * Age (\>80 years).

Primary Outcome Measure

Efficacy as Disease control rate (DCR) [ Time Frame: 32 months ]

Central Contacts

Find similar trials

Nationwide
Neuroendocrine tumors trialsOncology trials

Related Studies