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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Not Recruiting
Trial ID: NCT04919226
Purpose
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Official Title
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
Stanford Investigator(s)
Carina Mari Aparici
Clinical Professor, Radiology - Rad/Nuclear Medicine
Eligibility
Inclusion Criteria:
* Patients aged ≥ 18 years.
* Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
* Somatostatin receptor-positive (SSTR+) disease.
Exclusion Criteria:
* Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
* Prior (Peptide Receptor Radionuclide Therapy) PRRT.
* Any major surgery within 4 weeks prior to randomization in the trial.
* Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
* Other known malignancies.
* Serious non-malignant disease.
* Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
* Pregnant or breastfeeding women.
* Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
Intervention(s):
drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
drug: CAPTEM (Capecitabine and Temozolomide)
other: Amino-Acid Solution
drug: Everolimus
drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
David Marcellus
650-723-4547