RecruitingPhase 4NCT06016855

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

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

6 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Malignant Neoplasm in the Liver Digestive System Neuroendocrine Tumor G1 Digestive System Neuroendocrine Tumor G2 Metastatic Digestive System Neuroendocrine Neoplasm Pancreatic Neuroendocrine Tumor G1 Pancreatic Neuroendocrine Tumor G2

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial investigates whether surgically removing some of the tumor burden before receiving radioactive peptide therapy (PRRT, a type of targeted radiation) improves outcomes for people with slow-growing gut or pancreatic tumors (neuroendocrine tumors) that have spread to the liver. **You may be eligible if...** - You are 18 or older with a confirmed slow-growing neuroendocrine tumor of the gut or pancreas (grade 1 or 2) - You have liver metastases visible on a special nuclear medicine scan - You have not previously received PRRT - Your blood counts, kidney, and liver function meet required levels **You may NOT be eligible if...** - Any of your tumors larger than 3 cm cannot be surgically removed - Your disease is fully removable with surgery alone - You have grade 3 (fast-growing) neuroendocrine cancer - You have untreated or growing brain metastases - You have uncontrolled heart failure or serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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