Surgery Before Radiation Therapy for Treating Gastroenteropancreatic Neuroendocrine Tumors

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06016855

Provider View

This study is testing if removing as much of the tumor as possible through surgery, followed by a targeted radiation treatment, can effectively treat certain types of neuroendocrine tumors that have spread to the liver.

Patient Parameters

Program Overview

This clinical trial is exploring a treatment approach for patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread to the liver. The treatment involves first performing surgery to remove as much of the tumor as possible, known as debulking surgery. After surgery, patients receive a targeted radiation therapy using a drug called Lutetium Lu 177 dotatate. This drug targets tumor cells with a specific receptor, delivering radiation directly to them to help kill the cancer cells. The study aims to see if this combination of surgery and radiation therapy can better treat these tumors.

Description

The main goals of this study are to:

  1. Measure how well the combination of surgery and radiation therapy works in shrinking tumors in patients with gastroenteropancreatic neuroendocrine tumors.
  2. Evaluate the characteristics of the tumors, including how they absorb the treatment, and check for any signs of resistance to radiation.
  3. Assess the safety and side effects of the radiation therapy after surgery.

Patients will undergo surgery to remove as much of the tumor as possible. Following surgery, they will receive the radiation drug Lutetium Lu 177 dotatate through an IV every 56 days, for up to four cycles, unless the disease progresses or side effects become too severe. Throughout the study, patients will have regular scans to monitor the tumors and assess the treatment's effectiveness. After completing the treatment, patients will have follow-up visits to check their health and the status of the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Be 18 years or older.
  • Have a performance status that allows for daily activities with some limitations.
  • Have a confirmed diagnosis of grade 1 or 2 gastrointestinal or pancreatic neuroendocrine tumor.
  • Tumors must show a specific receptor on scans done within six months before surgery.
  • Must have cancer that has spread to the liver, but can also have other sites of spread.
  • Meet specific blood count and organ function requirements.
  • Women must not be breastfeeding and agree to avoid breastfeeding during and after treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
  • Men must agree to use contraception if sexually active with a woman of childbearing potential during and after treatment.

Exclusion Criteria

  • Tumors larger than 3 cm that cannot be surgically removed.
  • Cancer that can be completely removed by surgery.
  • Grade 3 neuroendocrine tumors.
  • Previous treatment with similar radiation therapy.
  • Untreated or growing brain metastases.
  • Severe heart conditions or uncontrolled heart rhythm problems.
  • Any other significant medical or psychiatric conditions that could interfere with completing the study.

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