NCT04790708

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale behind the purpose of this study lays on: * the evidence that PRRT could represent a valuable treatment for the majority of patients with neuroendocrine tumor (NET) in disease progression, operated or inoperable, presenting lesions expressing somatostatin receptors and for which standard treatments are not already available; * the current impossibility of acquiring on the market radiolabelled analogues of somatostatin used for PRRT with marketing authorisation; * the need to collect a larger case history than in previous studies; * the need to stratify the various histotypes based on the response obtained; * the need to define new treatment schemes that guarantee the maximum efficacy and the lowest possible toxicity - with low cumulative (and per cycle) activities radiopharmaceutical and according to the concept of dose hyperfractionation - with a view to an optimal balance between risk and benefit.

Conditions

• Neuroendocrine Tumors
• Peptide Receptor Radionuclide Therapy (PRRT)

Interventions

Type	Name	Description
RADIATION	Lutetium-177 (177Lu)-DOTATOC	5 cycles of 3,7 e 5,55 gigabequerel (GBq) of 177Lu-DOTATOC every 8-10 weeks. Cumulative activity: 18,5 e 27,75 GBq
RADIATION	Yttrium-90 (90Y)-DOTATOC	5 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 9,25 e 13,875 GBq
RADIATION	177Lu-DOTATOC + 90Y-DOTATOC	3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC alternated with 2 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 18,5 e 27,75 GBq of 177Lu-DOTATOC and 9,25 e 13,875 GBq of 90Y-DOTATOC
RADIATION	Re-treatment 177Lu-DOTATOC	3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC every 8-10weeks. Cumulative activity: 11,1 e 16,65 GBq of 177Lu-DOTATOC
RADIATION	Re-treatment 90Y-DOTATOC	3 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks Cumulative activity: 5,55 e 8,325 GBq of 90Y-DOTATOC

Timeline

• Start date: 2018-07-02
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-03-10
• Last updated: 2021-03-10

Locations

1 site across 1 country: Italy