Treatment of neuroendocrine tumours with radiolabelled somatostatin analogues

Evaluation of the efficacy of the tandem treatment [90Y-DOTA, TYR(3)]OCTREOTATE and [177Lu-DOTA, TYR(3)]OCTREOTATE in patients with neuroendocrine tumour expressing somatostatin receptors and refractory to conventional therapies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006234-16-IT

Enrollment

110

Registered

2012-03-05

Start date

2012-03-27

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Patients bearing neuroendocrine tumour expressing somatostatin receptors refractory to conventional therapies MedDRA version: 14.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 177Lu-DOTA, TYR(3)OCTREOTATE Product Code: 177Lu-DOTATATE Pharmaceutical Form: Radiopharmaceutical precursor INN or Proposed INN: other therapeutic radiopharmaceuticals CAS Number: NA Cu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histopathologic diagnosis of neuroendocrine tumour; TC or MRI scan within 3 months from enrollment; Nuclear medicine imaging showing an high expression of somatostatin receptors; ECOG performance status equal or lower than 2; Age over 18 years old; Measurableor evaluable disease; Adequate medullar reserve and renal functionality; Signed informed consent. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Concomitant non neoplastc serious diseases not adequately controlled; Pregnancy or lactation; Surgery or radiotherapy within two weeks from beginning of treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of clinical efficacy and toxicity of the tandem treatment with 177Lu-DOTA-TATE and 90Y-DOTA-TATE;Secondary Objective: Evaluation of Time to Progression (TTP);Primary end point(s): Evaluation of the clinical efficacy of the treatment;Timepoint(s) of evaluation of this end point: One year from beginning treatment	—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the time to progression;Timepoint(s) of evaluation of this end point: There isn't a definided timepoint: TTP is calculated at the progression of the disease or at the death of the patient.	—

Countries

Italy

Contacts

Public ContactTerapia Medico Nucleare

Fondazione IRCCS Istituto Nazionale dei Tumori

ettore.seregni@istitutotumori.mi.it02 23902688

Outcome results

None listed

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