Patients with malignant neuroendocrine tumours, not amenable to surgical treatment or radiofrequency ablation. Renal, bone marrow and liver function must be sufficient.
Conditions
Interventions
Trade Name: 177-LuDOTA-Tyr3-Octreotate
Product Name: 177-LuDOTA-Tyr3-Octreotate
Pharmaceutical Form: Solution for infusion
Sponsors
Department of Endocrine Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients either with carcinoids originating from lung, thymus, stomach, duodenum, small bowel, large bowel, rectum, or • Patients with endocrine pancreatic tumours, or • Patients with malignant pheochromocytoma/paraganglioma • Uptake at least grade 3 according to Krenning sckale (0–4) at OctreoScan, (i.e. somatostatin receptor expression higher than normal liver), not older than 6 months • Life exspektancy more than 3 months • WBC >3,0x109/L • Neutrophils >1,5x109/L • Platelet count >100x109/L • Bilirubin 25 g/L • ASAT/ALAT =5 times upper reference limit • Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Tumors accessible to surgery or radiofrequency ablation • Decreased renal function: Creatinine >110 µmol/L and/or GFR 20–30% (Ki67-positive tumour cells)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clarify the effect of the treatment with 177-Lu-DOTA-octreotate, regarding a) tumour size b) biochemical response, c) prognostic factors such as proliferation markers and LD/ALP and type of tumour, d) quality of life, e) survival and f) progression free survival.;Secondary Objective: Optimize the treatment based on a dosimetry protocol developed in Uppsala. Is it possible to safely administer more than the four treatments from the Rotterdam protocol based on this dosmetry model, and can the therapeutic effect be further improved over time?;Primary end point(s): Radiological response rate according to RECIST criteria | — |
Countries
Sweden
Outcome results
None listed