Radioreceptor therapy with labeled somatostatin analogues in tumors with high expression of somatostatin receptors.

Conditions: Patients with tumors expressing somatostatin receptors.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002605-65-IT

Lead Sponsor: Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients age > 18 years old and either gender or ethnicity
Cyto-histological diagnosis of NET or other SSTR-positive tumors (brain tumor cancer, colon cancer, differentiated thyroid carcinoma, lymphoma, breast cancer, melanoma, lung cancer, renal cancer, sarcoma, prostate cancer, hepatocellular carcinoma, thymic neoplasms)
Presence of at least one measurable lesion> 1 cm
High expression of somatostatin receptors in the 68Ga-SST-A PET / CT in / lesion and / i target. It is defined as high expression of somatostatin receptors demonstration examination 68Ga-SST-A PET / CT (semi-quantitative analysis) in a ratio of SUVmax tumor / muscle SUVmean> 4:1.
Examination CT with contrast or MRI <2 months of enrollment in this clinical study
Adequate serum chemistry values: white blood cell count> 2500/µL, platelets> 90000/µL; hemoglobin> 9 g / dL, creatinine <2 mg / dl, bilirubin <2.5 mg / dL
ECOG performance status = 2
Written informed consent

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Pregnancy status
In case of breastfeeding, refuse to stop breastfeeding
Surgery, chemotherapy, radiation therapy, or biological drugs in the 4 weeks preceding the PRRT (except radiotherapy with palliative intent of symptomatic lesions in patients plurimetastatici).
Participation in another clinical protocol experimental therapy within 4 weeks before the PRRT
Invasion of bone marrow disease ascertained> 25%
Patients with other therapeutic option validated as an effective
Life expectancy <6 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Correlate the dosimetric results of each lesion target with the response of the lesion to the radioreceptor therapy (PRRT) in patients with cyto-histological diagnosis of cancer or other neuroendocrine tumors expressing somatostatin receptors.;Secondary Objective: Correlate the dosimetric results of BED to the kidney and dose to the spinal forecast with nephrotoxicity and hematologic toxicity determined by the PRRT.;Primary end point(s): Assess for all patients undergoing PRRT survival at 3 and 6 months, the PFS and <br>ORR.<br>;Timepoint(s) of evaluation of this end point: 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlate the response to PRRT with the degree of histological differentiation at the time of diagnosis and the stage of disease at enrollment in this clinical study.;Timepoint(s) of evaluation of this end point: 3 and 6 months.