At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed well-differentiated neuroendocrine tumor of gastroenteric or pancreatic origin
- ✓Measurable disease by RECIST 1.1
- ✓Somatostatin receptor positive (SSTR+) disease
- ✓Progressive disease on RECIST 1.1 documented by two imaging studies (CT or MRI) using same modality
- ✕Prior peptide receptor radionuclide therapy (PRRT)
- ✕Prior mTOR inhibitor therapy
- ✕External field radiation to GEP-NET lesions within 90 days or prior radioembolization
- ✕Planned alternative therapy during study participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)
In Brief
A Phase 3 clinical trial evaluating 177Lu-edotreotide PRRT, Everolimus, and 1 other intervention for Neuroendocrine Tumors. Active but no longer recruiting, targeting 324 participants across 52 sites in 14 countries.
Detailed Summary
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Study Details
Timeline
Interventions
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT