Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b
This is a phase III study of Peptid Receptor Radionuclide Therapy (PRRT) with
177Lu-octreotate versus Interferon α-2b.
Objectives of the study:
1. To assess the benefit of 177Lu-octreotate versus interferon α-2b in patients with
progressive, unresectable,non-pancreatic gastrointestinal neuroendocrine tumors,
resistant to therapy with somatostatine analogues.
2. To assess efficacy and safety parameters of both treatment arms and the prognostic
value of tumor 68Ga-octreotate PET/CT and 18FDG PET/CT uptake at baseline, at mid and
end of PRRT treatment.
In the interferon arm: 5000000 Units of interferon will be administered subcutaneously
preferentially in the evening every second day.
In the 177Lu-octreotate arm: Treatment will consist of 177Lu-octreotate infusions in fixed
activities of 7,4 GigaBecqurel each, given 8-11 weeks apart, injected intravenously with
simultaneous infusion of an amino acid solution. (Before amino acid nephroprotection
solution, ondansetron, methylprednisolone and metoclopramid, are given intravenously in
order to prevent nausea or vomiting). Approximately 30 min after the beginning of the
aminoacid solution, 177Lu-octreotate is co-infused over 15-30 minutes. The amino acid
infusion is continued at the same rate for 3-5 more hours (total infusion lasts 4-6 hours).
In total, 4 cycles are planned. However, the total number of administered cycles will be
limited by critical organ (kidneys and bone marrow) cumulated absorbed doses.
Treatment efficacy will be assessed on a patient-basis by evaluation of the Progression-Free
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
3 years [Anticipated]
Patrick Flamen, M.D., Ph.D.
Jules Bordet Institute
Belgium: Federal Agency for Medicinal Products and Health Products