Preoperative therapy with radiopharmaceuticals for the treatment of pancreatic neuroendocrine tumors

Neoadjuvant peptide receptor radionuclide therapy (PRRT) with 90Y-DOTATOC in pancreatic neuroendocrine tumors - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003768-30-IT

Enrollment

Registered

2021-05-20

Start date

2019-11-12

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Pancreatic neuroendocrine tumors MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 90Y-DOTATOC Product Code: [90Y-DOTATOC] Pharmaceutical Form: Solution for infusion INN or Proposed INN: 90 Y DOTATOC Current Sponsor code: 90 Y DOTATOC Concentration unit: mCi millicurie

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients affected by unresectable or borderline resectable P-NETs and limited liver disease • Multidisciplinary evaluation in which a global therapy approach is proposed with PRRT in a neoadjuvant setting. • Histopathologic diagnosis G1/G2 • Conserved hematological, liver and renal parameters 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Pregnancy • Medullary invasion > 25%

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy and tolerability of peptide receptor radionuclide therapy in patients affected by pancreatic NETs;Secondary Objective: Evaluation of the progression free survival (PFS) and the possible association between histopathology characteristics (grading and proliferation index) and PFS.;Primary end point(s): objective response rate and feasibility of pancreatic surgery;Timepoint(s) of evaluation of this end point: 3 e6 months	—

Measure

Time frame

Main Objective: Evaluate the efficacy and tolerability of peptide receptor radionuclide therapy in patients affected by pancreatic NETs;Secondary Objective: Evaluation of the progression free survival (PFS) and the possible association between histopathology characteristics (grading and proliferation index) and PFS.;Primary end point(s): objective response rate and feasibility of pancreatic surgery;Timepoint(s) of evaluation of this end point: 3 e6 months

—

Secondary

Measure	Time frame
Secondary end point(s): • disease free survival; •association between histopathology characteristics and PFS, and the receptor status at Ga-68-peptides PET or OctreoScan©.;Timepoint(s) of evaluation of this end point: 3 e 6 months; 3 e 6 months	—

Countries

Italy

Contacts

Public ContactUfficio Studi Clinici e attività re

ISTITUTO EUROPEO ONCOLOGIA

ufficio.studiclinici@ieo.it02574898781

Outcome results

None listed

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