Preoperative therapy with radiopharmaceuticals for the treatment of pancreatic neuroendocrine tumors
Phase 1
- Conditions
- Pancreatic neuroendocrine tumorsMedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003768-30-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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
•Pregnancy
•Medullary invasion > 25%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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