OncoMatch/Clinical Trials/NCT06045260
"Receptor Radionuclide Therapy With 177Lu-DOTATOC
Is NCT06045260 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 177Lu-DOTATOC for neuroendocrine tumors.
Treatment: 177Lu-DOTATOC — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR2 overexpression (SSTr2 positivity by 68Ga PET-CT; Krenning Scale grade 3 or 4 in most lesions)
sst2-positive ... diagnostic PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour, according to the adapted Krenning Scale. Only patients with a greater caption (Grade 3 or 4) in most of the lesions will be admitted.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
ECOG performance status <2 (inclusion); ECOG performance status >2 (exclusion)
Prior therapy
Must have received: conventional standard treatments
Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed.
Cannot have received: chemotherapy
Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks
Cannot have received: therapeutic radiotherapy
Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks
Cannot have received: palliative radiotherapy
treated within 2 weeks with palliative radiotherapy
Cannot have received: hormonal therapy
treated within 2 weeks with ... hormonal ... therapy
Cannot have received: biological therapy
treated within 2 weeks with ... biological therapy
Cannot have received: external beam radiation therapy
Exception: to more than 25% of the bone marrow
Patients treated with prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
Cannot have received: PRRT
Exception: with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry
Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry
Lab requirements
Blood counts
haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 10^9 /L, platelets >= 100 x 10^9 /L
Kidney function
creatinine < 2 mg/dL and/or eGFR or creatinine clearance > 50 ml/min
Liver function
bilirubin ≤1.5 X UNL (upper normal limit), ALT and AST <2.5 X UNL (< 5 X UNL in presence of liver metastases)
Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 10^9 /L, platelets >= 100 x 10^9 /L, bilirubin ≤1.5 X UNL (upper normal limit), ALT and AST <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL and/or eGFR or creatinine clearance > 50 ml/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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