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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

Signed and dated written informed consent

Male or female >= 18 years of age on the day of signing informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =< 20%)

Disqualifiers

Patient has any tumor > 3 cm deemed to be inoperable

Patient has disease which is considered to be completely surgically resectable

Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)

Prior receipt of peptide receptor radionuclide therapy (PRRT)

Trial design

Treatments tested in this trial

  • Tumor Debulking
  • Lutetium Lu 177 Dotatate
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Copper Cu 64 Dotatate
  • Positron Emission Tomography

Treatment groups

6 Participants
are divided into 1 treatment group