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.
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
Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.
Brain metastases or any metastases extending into the spinal canal
Unable to obtain confirmation of payment coverage for any planned radiation treatment
Single group
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Lutetium Lu 177 Dotatate
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT and PET/CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Gallium Ga 68-DOTATATE
RadiationUndergo gallium Ga 68-DOTATATE PET/CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
Will evaluate acute grade 3+ non-hematologic toxicity (based on Common Terminology Criteria for Adverse Events version 5) compared to historical controls of peptide receptor radionuclide therapy alone. The list of non-hematologic acute grade 3+ treatment related adverse events will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance. An exact binomial test will then be used to compare the observed toxicity rate to the historical control rate, assessing if the observed rate significantly exceeds expected levels.
Incidence of Acute Grade 2+ Non-Hematologic Adverse Events
Non-hematologic acute grade 2+ treatment related adverse events will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance.
Response Rate
The response rate based on Response Evaluation Criteria in Solid Tumors criteria of both large and small lesions at 3 months following treatment will be calculated along with 95% exact confidence intervals.
Progression Free Survival
Progression free survival at 12 months will be estimated with the Kaplan-Meier method along with 95% confidence intervals.
Patient-Reported Health-Related Quality of Life
Patient reported outcome will be summarized as mean, median, first quartile, third quartile, and standard deviation.
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator