Peptide Receptor Radionuclide Therapy (PRRT) in advanced gastro-entero-pancreatic Neuroendocrine Tumors

Peptide Receptor Radionuclide Therapy (PRRT) with Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in advanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patients: a prospective phase II randomized study. - LUNET

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003165-34-IT

Enrollment

Registered

2013-10-07

Start date

2013-12-03

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patients MedDRA version: 16.0 Level: HLGT Classification code 10014713 Term: Endocrine neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 177 Lutetium DOTATATE Product Code: 177Lu-TATE Pharmaceutical Form: Solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: 177 Lu-TATE Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >18 years. - Patients must have histologically or cytologically confirmation of GEP–NETand Ki 67 index =65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: - Ki 67 index > 20 % - FDG PET positive at least in one documented lesion with a SUV more than 2.5 - Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels.;Secondary Objective: The secondary objectives are PFS, late toxicity and OS.;Primary end point(s): The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels.;Timepoint(s) of evaluation of this end point: CT scan every 6 months, blood tests every 2 weeks	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels.;Secondary Objective: The secondary objectives are PFS, late toxicity and OS.;Primary end point(s): The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels.;Timepoint(s) of evaluation of this end point: CT scan every 6 months, blood tests every 2 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary objectives are PFS, late toxicity and OS.;Timepoint(s) of evaluation of this end point: FUP visits with radiological evaluations and blood tests every 6 months	—

Countries

Italy

Contacts

Public ContactClinical trial unit

IRCCS-IRST di Meldola

o.nanni@irst.emr.it00390543739100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026