Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial
Emory University
Summary
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 large 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. 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.
Description
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 to…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female * Age ≥ 18 years * Patient must be able to provide study specific informed consent * Pathologically confirmed neuroendocrine tumor fulfilling all of the following criteria * Well-differentiated, grade 1-2 * Unresectable (prior resection is allowable), verified by tumor board or surgical oncology (surg onc) * Progression after one or two prior lines of systemic therapy * Somatostatin-receptor positive disease as determined by positive radiotracer-labeled DOTATATE PET/CT scan (modified Krenning score 3+) * One or more large lesions measuring 3 or more cm on…
Interventions
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
- DrugLutetium Lu 177 Dotatate
Given IV
- ProcedureComputed Tomography
Undergo CT and PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationGallium Ga 68-DOTATATE
Undergo gallium Ga 68-DOTATATE PET/CT
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Locations (2)
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University HospitalAtlanta, Georgia