Study on Preoperative PRRT Versus Surgery for Metastatic Pancreatic Neuroendocrine Tumors in the Liver

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05610826

Provider View

This clinical trial is exploring whether combining a targeted radiation treatment called PRRT with surgery is more effective than surgery alone for treating pancreatic neuroendocrine tumors that have spread to the liver. The study will last about 2 years and aims to gather information on the safety and effectiveness of this combination treatment.

Patient Parameters

Program Overview

The study aims to find out if using a targeted radiation treatment called peptide receptor radionuclide therapy (PRRT) along with surgery to remove tumors is more effective than surgery alone for treating pancreatic neuroendocrine tumors that have spread to the liver. PRRT is already approved for use in these types of tumors, but its combination with surgery is still experimental. Participants will be involved in the study for about 2 years to help researchers learn more about the safety and effectiveness of this treatment approach.

Description

This study is investigating whether combining a targeted radiation treatment called peptide receptor radionuclide therapy (PRRT) with surgery to remove tumors is more effective than surgery alone for treating pancreatic neuroendocrine tumors that have spread to the liver. PRRT is a targeted treatment that uses a small molecule called Lutathera, which acts like a key to lock onto specific areas on tumor cells. When injected into a vein, Lutathera travels through the bloodstream and delivers radiation directly to the tumor cells, helping to destroy them.

Before receiving PRRT, doctors will perform imaging tests to ensure that the tumors have the necessary receptors for the treatment to work. Participants will be randomly assigned to one of two groups: one group will receive standard surgery to remove the tumors, while the other group will receive four cycles of PRRT before undergoing surgery. The study will last about 2 years, and its purpose is to gather information on the safety and effectiveness of combining PRRT with surgery.

Eligibility Criteria

Inclusion Criteria

  • Have pancreatic neuroendocrine tumors that have spread to the liver.
  • Tumors must be well or moderately differentiated (grade 1 or 2).
  • Surgery should aim to remove at least 90% of the liver tumors.
  • Tumors must show specific receptor expression on imaging tests.
  • Be older than 18 years.
  • No treatment with somatostatin analogues or other systemic therapy for 4 weeks before starting PRRT, if assigned to that group.

Exclusion Criteria

  • Have poorly differentiated tumors (grade 3).
  • Previous liver-directed therapy with Yttrium-90 within the last 12 months.
  • Recent treatment with certain chemotherapy drugs within the last 12 months.
  • Tumors do not show uptake on specific imaging tests.
  • More than 50% of the liver is affected by tumors.
  • Signs of early liver failure or severe liver disease.
  • Poor kidney function.
  • Low blood cell counts.
  • Known brain metastases unless treated and stable.
  • Uncontrolled heart failure or diabetes.
  • Pregnant or breastfeeding women.
  • Not using effective contraception if of childbearing potential.
  • Previous extensive radiation therapy to the bone marrow.
  • Current urinary incontinence that prevents safe treatment.
  • Other untreated or active cancers.
  • Not provided signed consent for treatment.
  • Poor renal function.

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