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Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors — LUNET  

Neuroendocrine Tumors Clinical Trial

Official title:
Peptide Receptor Radionuclide Therapy (PRRT) With Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized Study

Clinical Trial Summary

This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).

Clinical Trial Description

This is a randomized phase II non-comparative study. Patients with GEP-NET G1-G2 with progressive disease, somatostatin receptor (SSR) positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq). The two levels of dosages are: 1. Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi) 2. Total activity of 18.5 GBq 100 mCi for 5 cycles at 6 ± 2 weeks (500 mCi) The randomized study design allows for two active treatments to be evaluated in a comparable patient population. The estimates of primary objectives can be evaluated for each regimen separately by a Bryant and Day design. While the sample size is not powered for statistical test of a specific hypothesis for comparison between groups, this study design allows the unbiased collection of activity and safety in these two regimens in the same population, which will be useful for planning future studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02489604
Study type Interventional
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 2013
Completion date December 2023
View Details
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