Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Not Recruiting

Trial ID: NCT03049189


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).

Official Title

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)

Stanford Investigator(s)

Carina Mari Aparici
Carina Mari Aparici

Clinical Professor, Radiology - Rad/Nuclear Medicine


Inclusion Criteria:

   - Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of
   non-functional gastroenteric origin (GE-NET) or both functional or non-functional
   pancreatic origin (P-NET)

   - Measurable disease per RECIST 1.1

   - Somatostatin receptor positive (SSTR+) disease

   - Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological
   imaging examinations made with the same imaging method (either CT or MRI)

Exclusion Criteria:

   - Known hypersensitivity to edotreotide or everolimus

   - Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or
   everolimus or any other Rapamycin derivative

   - Prior exposure to any peptide receptor radionuclide therapy (PRRT)

   - Prior therapy with mTor inhibitors

   - Prior EFR (external field radiation) to GEP-NET lesions within 90 days before
   randomisation or radioembolisation therapy

   - Therapy with an investigational compound and/or medical device within 30 days prior to

   - Indication for surgical lesion removal with curative potential

   - Planned alternative therapy (for the period of study participation)

   - Serious non-malignant disease

   - Clinically relevant renal, hepatic, cardiovascular, or haematological organ
   dysfunction, potentially interfering with the safety of the study treatments

   - Pregnant or breast-feeding women

   - Subjects not able to declare meaningful informed consent on their own (e.g. with legal
   guardian for mental disorders) or any other vulnerable population to that sense (e.g.
   persons institutionalised, incarcerated etc.).


drug: 177Lu-edotreotide PRRT

drug: Everolimus

other: Amino-Acid Solution

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Marcellus

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