The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
309
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
progression-free survival (PFS)
PFS will be assessed individually per patient from date of randomization until the date of first documented progression or death, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
Time frame: 12 weeks +/- 14 days, up to 30 months
objective response rates (ORR)
ORR will be assessed, defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus
Time frame: 12 weeks +/- 14 days, up to 30 months
overall survival (OS)
OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death
Time frame: 12 weeks +/- 14 days, up to 90 months
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