Treatment of neuroendocrine tumours with radiolabelled somatostatin analogues
- Conditions
- Patients bearing neuroendocrine tumour expressing somatostatin receptors refractory to conventional therapiesMedDRA version: 14.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006234-16-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Concomitant non neoplastc serious diseases not adequately controlled; Pregnancy or lactation; Surgery or radiotherapy within two weeks from beginning of treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.