Diagnosed and confirmed histopathologically disseminated or locally unresectable, well and moderately differentiated (G1 and G2) neuroendocrine neoplasms of the gastrointestinal tract (GEP-NET)
Conditions
Interventions
Product Name: DuoNEN
Product Code: DOTA-TATE, [177Lu]Lu-DOTA-TATE, [90Y]Y-DOTA-TATE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DOTA-TATE
CAS Number: 177943-89-4
Current Sponsor
Sponsors
Narodowe Centrum Badan Jadrowych, Osrodek Radioizotopów POLATOM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I. Related to the neuroendocrine tumor a) advanced, unresectable, confirmed in histopathological test, well and moderately differentiated (G1 and G2) neuroendocrine neoplasms, in which high expression of somatostatin receptors have been confirmed by Somatostatin Receptor Imaging (SRI) in PET/CT using 68Ga-DOTA-TATE, which has been performed not earlier than 12 weeks prior to qualification. b) disease progression according to RECIST 1.1 criteria diagnosed in multiphase CT or dynamic MRI within 18 months, given the qualification investigation is performed not earlier than 12 weeks prior to qualification. c) Laboratory test: ? morphology with smear Hb > 9g/dl, platelets > 100 tys./µl, leukocytes > 3 k/µl, neutrocytes > 1,5 k/µl, ? creatinine 45 ml/min. ? AlAT, AspAT, total bilirubin (values not higher than 3x reference standard) II. Related to the patient Overall status of the patient in Karnofsky’s scale =60%. Expected life span over 6 months. Age over 18 years, no age limit in adults. Ability to express informed consent to take part in the trial. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: I. Related to the neuroendocrine tumor Disability of the patient (Karnofsky <60) Expected life span below 6 months Anther malignant neoplastic disease treatment within 5 years prior to randomization Related to current therapies and medical interventions or those in the past Earlier PRRT Chemotherapy or molecular therapy (due to NEN or another neoplasm) in the past II. Related to the patient Age less than 18 years Pregnancy or breast feeding Patients with urinary flow disorders or with non-treated urinary incontinence without catheter protection. Disability to express informed consent to take part in the trial. Unsigned informed consent form for taking part in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to develop an algorithm for the treatment of GEP-NET patients using ItraPol and LutaPol isotope mixtures (177Lu-DOTATATE and 90Y-DOTATATE) based on personalized dosimetry.;Secondary Objective: The specific goal is to assess the effectiveness and safety of personalized treatment of GEP-NET patients using 177Lu-DOTATATE and 90Y-Lu-DOTATATE mixtures compared to standard treatment of NEN patients using 177Lu-DOTATATE;Primary end point(s): Disease progression assessed by CT or MRI according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Timepoints of Primary End Point evaluation: control imaging investigations (CT or MRI) using the technique identical with the one based on which the patient was qualified for the trial, performed after 3,6,12,24,36,49,60 months after completion of therapy with assessment according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of effectiveness and safety of personalized therapy ;Timepoint(s) of evaluation of this end point: It is planned to perform biochemical tests during visit W1, during hospitalization and in the course of observation every 3 months (tests of blood morphology, urea, creatinine, eGFR, bilirubin). Total volume of blood collected at single timepoint - 6.8 ml. | — |
Countries
Poland
Contacts
Public ContactProject Leader, dr R. Mikolajczak
Narodowe Centrum Badan Jadrowych, Osrodek Radioizotopów POLATOM
Outcome results
None listed