Patient with tumour expressing somatostatine receptors MedDRA version: 14.1 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: NA
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: 90Y-DOTATOC
Concentration unit: mCi millicuri
Sponsors
AZ. USL DI CESENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female;> 18 years old, proven diagnosis of NET;progression of disease; no other valid therapeutic options available; adequate hematological, renal, hepatic parameters; measurable disease according to RECIST 1.1; no other anticancer treatments within 30 days (somatostatine analogs are permitted; informed consent signed by patients Are the trial subjects under 18? no Number of subjects for this age range: 0 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 25
Exclusion criteria
Exclusion criteria: no pregnancy or lactation; medullary invasion >= 50%; no previous emibody RT, ECOG PS > 2;life expectancy < 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: disease control rate;Secondary Objective: PFS, OS, toxicity, QoL, to compare different response evaluation methods.;Primary end point(s): disease control rate;Timepoint(s) of evaluation of this end point: 12-18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS, OS, toxicity, QoL, to compare different response evaluation methods.;Timepoint(s) of evaluation of this end point: 2-6 years | — |
Countries
Italy
Contacts
Public ContactUO Medicina Nucleare, Ospedale Bufa
UO Medicina Nucleare, Ospedale Bufalini Cesena
Outcome results
None listed