Comparing Retreatment with 177Lu-DOTATATE PRRT Versus Everolimus in Patients with Advanced Midgut Neuroendocrine Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05773274

Provider View

This clinical trial is comparing two treatments for patients with advanced midgut neuroendocrine tumors that cannot be removed by surgery. The study aims to find out if retreatment with 177Lu-DOTATATE, a type of targeted radiation therapy, is more effective than the usual treatment with the drug everolimus.

Patient Parameters

Program Overview

This study is testing two different treatments for patients with midgut neuroendocrine tumors that have spread and cannot be surgically removed. One treatment involves using 177Lu-DOTATATE, a targeted radiation therapy that attaches to cancer cells and helps destroy them. The other treatment uses everolimus, a medication that stops cancer cells from growing and reduces their blood supply. The trial will compare how well these treatments work in slowing down the progression of the cancer and improving patients' quality of life.

Description

The main goal of this study is to see if retreatment with 177Lu-DOTATATE can help patients live longer without their cancer getting worse, compared to the usual treatment with everolimus. The study will also look at the safety and side effects of both treatments, how well they shrink or stabilize tumors, and their impact on patients' overall survival and quality of life.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will receive 177Lu-DOTATATE through an IV every 8 weeks for up to two cycles, as long as the cancer does not progress and side effects are manageable. They will also have CT scans and blood tests during the study.

  • Group 2: Patients will take everolimus pills daily, continuing as long as the cancer does not progress and side effects are manageable. If the cancer worsens, they may switch to the 177Lu-DOTATATE treatment. They will also have CT scans and blood tests during the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced midgut neuroendocrine tumors that cannot be surgically removed, confirmed by specific scans.
  • Previously received 3 or 4 cycles of 177Lu-DOTATATE treatment.
  • Cancer must have shown progression after previous treatment but not before 12 months from the last scan.
  • No other treatments received after initial 177Lu-DOTATATE therapy.
  • Good overall health with specific blood counts and organ function.
  • Women of childbearing potential must use effective contraception during and after treatment.
  • Must be willing to sign a consent form and follow study procedures.
  • Must have access to everolimus if assigned to that treatment group.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Patients with other cancers that do not interfere with the study are eligible.

Exclusion Criteria

  • Major surgery within 6 weeks before starting the study.
  • Untreated or unstable brain metastases.
  • Severe heart failure.
  • Difficulty swallowing or absorbing oral medications.
  • Other uncontrolled medical conditions that could interfere with the study.
  • Pregnant or breastfeeding women are not eligible due to potential risks to the baby.

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