Therapy with radiopharmaceutical for the treatment of tumors
Phase 1
- Conditions
- euroendocrine tumors in progression of disease and not suitable to additional treatments, positive to SSTRMedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003268-11-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 29
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
•pregnancy
•verified medullary invasion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Evaluation of treatment tolerability and measurement of progression free survival (PFS).<br>;Timepoint(s) of evaluation of this end point: 24 months