Diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumour of the gastrointestinal tract
Conditions
Brief summary
Disease progression assessed by CT or MRI according to RECIST 1.1. 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
Detailed description
Assessment of effectiveness and safety of personalized therapy. 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.
Interventions
DRUGDuoNEN solution for injection
Sponsors
Narodowe Centrum Badan Jadrowych
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease progression assessed by CT or MRI according to RECIST 1.1. 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 |
|---|---|
| Assessment of effectiveness and safety of personalized therapy. 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
Outcome results
None listed