Diagnosis of tumor classified as expressing SSRT2, the main class of tumors to be included in the study are advanced and metastatic neuroendocrine tumors but also breast, lungs and thyroid cancers always expressing SSRT2. MedDRA version: 6.1 Level: PT Classification code 10052399
Conditions
Interventions
Product Name: 90-Y-DOTATOC
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: OTHER THERAPEUTIC RADIOPHARMACEUTICALS
Current Sponsor code: 90Y DOTATOC
Concentration unit: MBq mega
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years old or above Diagnosis of tumor classified as expressing SSRT2, the main class of tumors to be included in the study are advanced and metastatic neuroendocrine tumors but also breast, lungs and thyroid cancers always expressing SSRT2. Tumors selected can be evaluated with WHO answer criteria or, in case of secreting tumors, monitoring the specific secretion. Patients selected don t have possibility to be treated with other consolidated treatments Performance status 2 Preserved hematological, hepatic and renal parameters Patients mustn t be treated with any treatment chemotherapy or radiotherapy one month before and two months after the therapy with 90Y-DOTATOC or 177Lu-DOTATATE Patients with written informed consent after reception of detailed written ad oral information about the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Renal function compromised or hematological parameter compromised. Pregnancy breast feeding will be stopped Bone marrow invasion 25 Patients with other neoplastic lesions basalioma in situ and cervical cancers excluded Patients with life expectation 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the answer two months after the treatment using WHO criteria for measurable not secreting tumor evaluation done with Positron Emission Tomography using 68Ga-DOTATOC, Single Foton Emission Tomography using 111In-DOTATOC, or with TAC to reveal number and size, or with SUV to verify uptake variations . For secreting tumors will be evaluated both markers expression and dimensions of the lesion/s answer will be evaluated two months after the treatment.;Secondary Objective: Improvement of clinical symptoms in relation with basal differenced for tumor types Free time before illness resumption Life Quality before therapy and tree months after in accordance with Karnowski Method Global surviving and/or illness status 6, 12, 24 months after the therapy;Primary end point(s): Verify the effectiveness of 90Y-DOTATOC or 177Lu-DOTATATE radiopharmaceuticals for the treatment of selected neoplastic lesions. | — |
Countries
Italy
Outcome results
None listed