Neuroendocrine Tumors Clinical Trial
Official title:
Clinical Study of the Use of Yttrium-90 (90Y) and/or Lutecium-177 (177Lu) DOTATATE (DOTA-0-Tyr3-Octreotate) in the Treatment of Disseminated and / or Symptomatic Tumors With Somatostatin Receptor Overexpression
This is a non-randomized phase II , open label, comparative study. Patients with advanced non-resectable and/or progressive gastro-entero-pancreatic Neuroendocrine Tumours - GEP-NET, (G1, G2 and G3), Broncho-pulmonary Carcinoids (BPCs Atypical-AC or Typical-TC), pheochromocytoma/paraganglioma (PPGLs) and neuroendocrine tumours of unknown primary (NET-CUP) with overexpression of somatostatin receptor (SSTR positive) will be enrolled in the study and will be treated using Peptide Receptor Radionuclide Therapy (PRRT) initially with Yttrium-90 (90Y) DOTATATE (DOTA-0-Tyr3-Octreotate), and then compare to Lutecium-177 (177Lu) DOTATATE or mix of both Yttrium-90 (90Y) and Lutecium-177 (177Lu) DOTATATE. Total maximum activity for Yttrium-90 up to 4x3,7GBq, for Lutecium-177 up to 4x5,55GBq (Lu-177) and for both (mix) 4x3,7GBq (90Y and 177Lu 50% each).
This is a non-randomized phase II, open-label, comparative study. Patients with advanced,
unresectable and/or progressive Gastro-Entero-Pancreatic Neuroendocrine Tumors - GEP-NET,
(histological grade G1, G2 and G3), Broncho-Pulmonary Carcinoids (BPCs), including typical
carcinoid (AC) and typical carcinoid (TC), pheochromocytoma/paragangliomas (PPGLs) and
neuroendocrine tumors (cancers) of unknown primary (NET-CUP). All with overexpression of
somatostatin receptor (SSTR positive) based on somatostatin receptor imaging (scintigraphy or
PET), will be enrolled in this study.
Initially patients will be assigned to single arm of PRRT using yttrium-90 (90Y) DOTATATE
(DOTA-0-Tyr3-Octreotate) and then patients will be non-randomly assigned to one of the two
groups lutecium-177 (177Lu) DOTATATE or mix yttrium (90Y) DOTATATE and lutecium-177 (177Lu)
DOTATATE (50% each). The dosages (total activity used in each group of treated patients will
be as follows:
1. Total activity of 90Y DOTATATE 4x3,7GBq (14,8 GBq) for 4 cycles at 8 ± 2 weeks (400mCi)
2. Total activity of 177Lu DOTATATE 4x5,55GBq (22,2 GBq for 4 cycles at 8 ± 2 weeks (600
mCi)
3. Total activity of mix both 90Y DOTATATE and 177Lu DOTATATE (50 each) 4x3,7 GBq for 4
cycles at 8 ± 2 weeks (400mCi).
The non-randomized, phase II study design, allows for proposed initial active treatment arm
using standard dose of 90Y DOTATATE and experimental treatment arm which composed of two
options of PRRT with lutecium-177 DOTATATE or mix 90Y and 177Lu DOTATATE. The experimental
therapy arm will be consisting of randomly allocated patients.
Subjects including in this study will be evaluated in the mixed patients' population,
including GEP-NET, bronchopulmonary carcinoid (BPCs), paraganglioma/pheochromocytomas (PPGLs)
and NET of unknown origin (NET-CUP).
Estimates of the original goals of the study can be assessed for each scheme separately using
a two-step design using an external standard for comparison (the investigator's previous
published results include standard PRRT using 90Y DOTATATE in subjects with GEP-NET).
Although the sample size in this study is not based on any specific statistical hypothesis to
compare separate groups of patients those with PRRT using 90Y DOTATATE, next those with 177Lu
DOTATATE and those who will receive mix 90Y and 177Lu DOTATATE.
This study design allows an objective set of clinical efficacy results in terms of PRRT
responses and safety in these three treatment regimens in the same patient population, even
different groups of tumors, which may be useful when planning next generation of the clinical
trial using PRRT.
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