Therapy with radiopharmaceutical for the treatment of tumors

Peptide Receptor Radionuclide Therapy with 90Y-DOTATOC in patients with somatostatin receptor positive tumors (neuroendocrine tumors) - NA

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003268-11-IT

Enrollment

Registered

2020-11-04

Start date

2019-02-20

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Neuroendocrine tumors in progression of disease and not suitable to additional treatments, positive to SSTR 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: 90Y-DOTATOC Current Sponsor code: 90Y-DOTATOC Concentration unit: mCi millicurie(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histopathological diagnosis of sst2 positive neuroendocrine tumor metastatic or inoperable • Significant capitation of the tumor tissue using diagnostic imaging with OctreoScan or PET with 68Ga-octreotide • PET/TC with 18F-FDG • Patients should not have received additional treatments (for example chemotherapy or radiotherapy) from one month before to two months after completing the treatment with 90Y-DOTATOC 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: • pregnancy • verified medullary invasion

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate efficacy, in terms of response rate;Secondary Objective: Secondary objectives of the study is to evaluate tolerability and PFS;Primary end point(s): Evaluation of antitumoral activity in term of objective response;Timepoint(s) of evaluation of this end point: 12 months	—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of treatment tolerability and measurement of progression free survival (PFS). ;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Italy

Contacts

Public ContactUfficio Studi Clinici

Istituto Europeo Oncologia

ufficio.studiclinici@ieo.it0257489848

Outcome results

None listed

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