This phase I trial tests the safety and effectiveness of stereotactic body radiation therapy (SBRT) followed by 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in treating patients with well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery (unresectable). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. 177Lu-DOTATATE is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. 177Lu-DOTATATE builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving PRRT after SBRT may reduce the chances of the disease returning or getting worse, compared to the standard treatment of PRRT alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07150546.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Pretesh Ramanlal Patel
Phone: 404-778-1900
Emory University Hospital MidtownStatus: Approved
Contact: Pretesh Ramanlal Patel
Phone: 404-778-1900
PRIMARY OBJECTIVE:
I. To determine the rate of acute grade 3+ non-hematologic toxicity of PRRT after external radiation compared to historical control of PRRT alone.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ toxicity compared to historical control of PRRT alone.
II. To determine response rate of both large and small lesions at 3 months following treatment.
III. To determine progression free survival.
IV. To describe patient-reported outcomes (PROs) of toxicity.
OUTLINE:
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive standard of care (SOC) lutetium Lu 177 dotatate (177Lu-DOTATATE) intravenously (IV) once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial and undergo gallium Ga 68-DOTATATE positron emission tomography (PET)/CT before treatment.
After completion of study treatment, patients are followed up at 90 days and then every 3 months for 12 months.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorPretesh Ramanlal Patel