Gastro-intestinal Neuroendocrine Tumors Clinical Trial
Official title:
Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b
The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control.
This is a phase III study of Peptid Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE
versus Interferon α-2b.
Objectives of the study:
1. To assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with
progressive, unresectable,non-pancreatic gastrointestinal neuroendocrine tumors,
resistant to therapy with somatostatin analogues, in terms of disease control.
2. To assess efficacy and safety parameters of both treatment arms and the predictive
value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake at baseline, at mid (+/-
16th week) and end (+/- 32th week) of treatment in both arms.
In the interferon arm: 5000000 Units of interferon will be administered subcutaneously
preferentially in the evening three times a week (every other day) until disease
progression.
In the 177Lu-octreotate arm: Treatment will consist of 177Lu-DOTATATE intravenous injections
fractionated in fixed activities of 7,4 GigaBecquerel (200mCi) (+/- 5%), given every 8 (+/-
1) weeks with simultaneous nephroprotective infusion of an amino acid solution. (Before
amino acid nephroprotection solution, ondansetron, methylprednisolone and metoclopramid, are
given in infusions in order to prevent nausea or vomiting). Approximately 30 min after the
beginning of the aminoacid solution, 177Lu-octreotate is injected via a second side-line
over 15-30 minutes. The amino acid infusion is continued at the same rate until end (total
infusion time: 4-6 hours).
In total, 4 injections of 177Lu-DOTATATE are planned. However, in respect of the absorded
dose limits of critical organs(kidneys and bone marrow), the 4th 177Lu-DOTATATE injection
will be tailored with a minimal administered activity of 4,6 GigaBecquerel.
Treatment efficacy will be assessed on a patient-basis using RECIST 1.1 and by Progression
Free Survival. The value of tumor 68Ga-DOTATATE PET/CT and 18FDG PET/CT uptake as predicting
imaging biomarkers will also be assessed in both arms.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment