cancer patients MedDRA version: 14.1 Level: HLGT Classification code 10014713 Term: Endocrine neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: LU 177 DOTATATE
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NLutez
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: disease control rate, DCR, defined as the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start;Timepoint(s) of evaluation of this end point: years;Secondary Objective: Late and acute toxicity - PFS (progression free survival) - OS (overall survival) - to combine with appropriate statistical methods, the data of the present study and the previous one already concluded (data in press) - to evaluate clinical endpoints (DCR, PFS, OS) in two subgroups of patients according to the disease status at study entry: PD (progression of disease within 12 months before study entry) and other status of disease - to investigate the predictive value of FDG-PET/CT on PFS.;Primary end point(s): The main objective of this phase II study is to consolidate the role of 177Lu-DOTATATE in the management of neuroendocrine tumors and other sst2 positive tumours in terms of disease control rate, DCR, defined as the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population with no risk factors and on patient population with at least one risk factor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Late and acute toxicity - PFS (progression free survival) - OS (overall survival) - to combine with appropriate statistical methods, the data of the present study and the previous one already concluded (data in press) - to evaluate clinical endpoints (DCR, PFS, OS) in two subgroups of patients according to the disease status at study entry: PD (progression of disease within 12 months before study entry) and other status of disease - to investigate the predictive value of FDG-PET/CT on PFS.;Timepoint(s) of evaluation of this end point: years | — |
Countries
Italy
Contacts
Public ContactUfficio relazioni con il pubblico
IRST
Outcome results
None listed