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

Conditions: Advanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patients
MedDRA version: 16.0Level: HLGTClassification code 10014713Term: Endocrine neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-003165-34-IT

Lead Sponsor: IRCCS-IRST of Meldola

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Age >18 years.
-Patients must have histologically or cytologically confirmation of GEP–NETand Ki 67 index <= 20%.
-Measurable disease according to RECIST 1.1.criteria
-advanced GEP–NET are elegible; patients must have progressive disease based on RECIST 1.1. criteria
-Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
-FDG PET negative (SUV less than 2.5)
-ECOG <2
-No previous oncological treatments within 4 weeks
-No previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow
- signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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