Health TrialsbyHealthPanel

"Receptor Radionuclide Therapy With 177Lu-DOTATOC

ConditionsNeuroendocrine TumorsParagangliomaPheochromocytoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there are not any other effective treatments, included locoregional methods of control for PPGLs/pheochromocytoma. For cerebral and PPGLs sst2- positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity.

Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled.

Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the 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.

Disqualifiers

Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.

Known hypersensitivity to lutetium-177 (177Lu), edotreotide, DOTA or components of the formulation or other radiolabeled peptide agents.

Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective aminoacids given concurrently with the lutetium (177Lu) edotreotide infusion;

Patients treated with prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 7.4 Gbq DoseExperimental treatment 1 intervention
Group B: 5.5 Gbq DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy 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

Secondary outcomes

1

(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
2

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
3

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
4

Quality of life

Evaluated through validated standardized data collection forms from the EORTC QLQ-C30 questionnaire.

Time frame
32 months

Other outcomes

Sponsors and contacts

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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Lead sponsor

Source ClinicalTrials.gov
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