Radiometabolic treatment with 90Y-DOTA0-Tyr3]-octreotide (90Y-DOTATOC) or[90Y-DOTA0-Tyr3-Thr8]-octreotate (90Y-DOTATATE)in tumours expressing somatostatin receptors

• Conditions: Patient with tumour expressing somatostatine receptors; MedDRA version: 14.1Level: 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: EUCTR2012-003155-11-IT
• Lead Sponsor: AZ. USL DI CESENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

no pregnancy or lactation; medullary invasion >= 50%; no previous emibody RT, ECOG PS > 2;life expectancy < 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified