Patients with Somatostatin receptors Neoplasms MedDRA version: 20.0 Level: HLGT Classification code 10014713 Term: Endocrine neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [90Y-DOTA0-Tyr3]-octreotide (90Y-DOTATOC)
Product Code: [(90Y-DOTATOC)]
Pharmaceutical Form: Solution for infusion
Sponsors
AZIENDA UNITÀ SANITARIA LOCALE DELLA ROMAGNA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Will be enrolled for treating patients: • of both sexes; • age = 18 years and = 85 years; • histologic and immuno-histochemical diagnosis of endocrine tumor with limitation to gastroenteropancreatic and bronchial districts; • grading (evaluated on the basis of the cell proliferation index with Ki-67 (Mib1): 1 and 2 and 3 (non-differentiated forms with ki67> 55%); For bronchial NETs, ¿¿typical and atypical carcinoids will be enrolled without any limitations of positive k67 positive for sstr2 receptors. • documented high expression of somatostatin receptors documented by PET-TC with 68Ga-DOTATOC • for which standard treatments which are already documented and of equal effectiveness are not proposed; • with stored hematologic, hepatic and renal parameters, in particular: GB = 2.5 10 ^ 9 / L, Hb = 10 g / dL, PTL = 100,000 10 ^ 9 / L, Total Bilirubin = 2.5 mg / dL, Creatinine = 2.0 md / dl; • with parametrizable disease according to the RECIST 1.1 criteria by conventional imaging (TC or RMN) not earlier than three months compared with the enrollment; • who have not received chemotherapy and / or radiotherapy treatments for at least 30 days, although concomitant therapy with somatostatin analogues has been allowed; • who, duly informed, gave their consent to the study by signing the informed consent form. 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Will be excluded from the treatment of patients: • not in possession of the above-mentioned requirements; • pregnant or lactating; • with proven bone marrow invasion (= 50%); • previous RT emibody; • with ECOG performance status> 2; • with life expectancy <6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease control;Secondary Objective: PFS, OS, Adverse events;Primary end point(s): Desease control;Timepoint(s) of evaluation of this end point: 12-18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS, PFS, Adverse events;Timepoint(s) of evaluation of this end point: 2-6 years | — |
Countries
Italy
Contacts
Public ContactUFFICIO RICERCA
AUSL DELLA ROMAGNA
Outcome results
None listed