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Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)

ConditionsPheochromocytomasParagangliomas
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS

About this trial

This multicenter retrospective Italian study evaluates the efficacy and safety of PRRT in patients with advanced, unresectable or metastatic pheochromocytomas and paragangliomas (PPGL). Data from \~210 patients treated between 2000 and 2024 will be analyzed. The primary endpoint is disease control rate (DCR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and prognostic factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented diagnosis of pheochromocytoma or paraganglioma (PPGL) (sporadic or hereditary forms) with unresectable or metastatic disease.

Treatment with peptide receptor radionuclide therapy (PRRT) administered with ⁷⁷Lu and/or ⁹⁰Y (including combination regimens), with t0 (first PRRT administration) between January 1, 2000 and February 28, 2024.

Availability of essential data required by the protocol to document exposure (PRRT) and outcomes, including: PRRT start date (t0) and treatment details (radioisotope(s), number of cycles and/or cycles actually administered, intervals when available), At least one post-treatment evaluation suitable for determining disease control rate (DCR) (morphological imaging by CT/MRI ± functional imaging by PET/CT, and available clinical data), Follow-up information suitable for determining progression-free survival (PFS) within the predefined time window.

Availability of follow-up up to 12 months from end of treatment (EoT), or documentation of progression and/or death occurring within 12 months.

Disqualifiers

Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).

Trial population

Patients with sporadic or hereditary paraganglioma and pheochromocytoma (PPGL) with unresectable or metastatic disease, treated with peptide receptor radionuclide therapy (PRRT).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Peptide Receptor Radionuclide Therapy (PRRT)

    Radiation

    PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: MONO 177Lu1 intervention
Group B: MONO 90Y1 intervention
Group C: TANDEM 177Lu + 90Y1 intervention

Trial outcomes

Primary outcomes

1

Disease Control Rate (DCR)

To describe the effectiveness of PRRT in terms of disease control rate (DCR) in the overall population and by line of treatment (early vs late).

Time frame
baseline, 12 months

Secondary outcomes

1

Progression-Free Survival (PFS)

To evaluate progression-free survival (PFS) after PRRT in the overall population and by line of treatment (early vs late).

Time frame
baseline, 12 months
2

Overall Survival (OS)

To evaluate overall survival (OS) at 1 year after completion of PRRT, including analysis by response category (complete response, partial response, stable disease, progressive disease).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda USL Reggio Emilia - IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: