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Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Dec 15, 2025, no change to tracked fieldsv4-v5
  2. Primary completion date: Feb 28, 2027 to May 28, 2027 Completion date: Feb 28, 2028 to May 28, 2028 · Start date changed from estimate of Apr 30, 2024 to May 31, 2024v3 Show 2 more changesShow less
    • Completion date: Feb 28, 2028 to May 28, 2028
    • Start date changed from estimate of Apr 30, 2024 to May 31, 2024
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 31, 2025 to Feb 28, 2027 · Start date: Sep 1, 2023 to Apr 30, 2024 · Completion date: Mar 31, 2026 to Feb 28, 2028 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2025 to Feb 28, 2027
    • Start date: Sep 1, 2023 to Apr 30, 2024
    • Completion date: Mar 31, 2026 to Feb 28, 2028
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs
Trial Details
NCT Number NCT06016855
Lead Sponsor Vanderbilt-Ingram Cancer Center
Conditions Digestive System Neuroendocrine Tumor G1, Digestive System Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor G1, Pancreatic Neuroendocrine Tumor G2
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov