Phase II Study Comparing 177Lu-DOTATATE Retreatment to Everolimus, Sunitinib, or Cabozantinib in Adults With Metastatic or Unresectable Gastroenteropancreatic Neuroendocrine Tumors

What this Trial Is About

The trial focuses on patients with metastatic or unresectable gastroenteropancreatic neuroendocrine tumors GEPNET that have spread and cannot be removed by surgery. It compares retreatment using 177Lu-DOTATATE peptide receptor radionuclide therapy PRRT with the usual treatments of everolimus, sunitinib, or cabozantinib. The study aims to evaluate whether retreatment with 177Lu-DOTATATE can better delay tumor progression compared to these established therapies. This is a phase II trial sponsored by the National Cancer Institute NCI. Participants are randomly assigned to one of two treatment groups. One group receives 177Lu-DOTATATE intravenously every 8 weeks for two cycles if no disease progression or unacceptable side effects occur. The other group receives daily oral treatment with everolimus, sunitinib for pancreatic NET patients only, or cabozantinib for U.S. patients only, continuing until disease progression or unacceptable toxicity. Patients in the oral treatment group whose cancer worsens may switch to the 177Lu-DOTATATE group. Both groups undergo CT or MRI scans and blood sample collections during the study. Throughout the study, participants are monitored with imaging scans and blood tests to assess tumor response and safety. Researchers measure progression-free survival as the primary outcome, looking at the time from randomization until tumor progression or death, tracked for up to three years. Secondary measures include overall survival, response rates, quality of life assessments, and post-progression outcomes. After treatment ends, participants have follow-up visits every 12 weeks until disease progression, then every 6 months until death, to continue monitoring their health and study outcomes.

Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial