Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)

Washington University School of Medicine

Summary

This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Histologically or cytologically confirmed metastatic, unresectable, well- or moderately-differentiated, nonfunctional gastrointestinal neuroendocrine tumor (GI-NETs). This includes pancreatic neuroendocrine neoplasms. Any grade (grade 1, grade 2, or grade 3) is permitted. * Measurable disease per RECIST 1.1. * Appropriate for ethanol-stabilized Lu-177 dotatate treatment, as determined by positive screening with SSTR PET/CT and/or currently having received up to 3 fractions of PRRT. (Patients will be randomized prior to the start of PRRT or during PRRT, depending on the t…

Interventions

Drug
Somatostatin Analogue(s)
SSA will be administered according to standard of care guidelines.

Locations (2)

University of California - San Francisco
San Francisco, California
415-476-1000
Washington University School of Medicine
St Louis, Missouri
ntrikalinos@wustl.edu 314-273-4959

Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions