Receptorial radiotherapy with 177Lu DOTATATE in somatostatine receptors positive tumours, a phase II study.
- Conditions
- cancer patientsMedDRA 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
- EUCTR2011-002891-18-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histotype documented as sst2-positive (breast, small cell lung cancer, Hodgkin and Non-Hodgkin lymphoma, high-grade glioma etc…….), that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. Any disease stage is allowed. Patient could be enrolled with progressive disease (PD within the last 12 months from treatment start) but also with non progressive disease. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- pazienti già trattati con 177Lu-dotatate o 90Y-dotatoc, a dosi cumulative superiori a 600 mCi e 200 mCi rispettivamente - pazienti trattati con CT e RT da meno di 4 settimane - pazienti con gravi comorbidità
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method