Actively Recruiting
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
Led by Emory University · Updated on 2026-03-02
15
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18 years or older
- Able to provide informed consent
- Pathologically confirmed well-differentiated grade 1-2 neuroendocrine tumor
- Tumor is unresectable (previous surgery allowed), confirmed by tumor board or surgical oncology
- Disease progression after one or two prior systemic therapies
- Somatostatin-receptor positive disease by positive DOTATATE PET/CT scan (modified Krenning score 3+)
- At least one lesion 3 cm or larger on contrast-enhanced CT or MRI
- ECOG performance status 0 to 2
- Estimated glomerular filtration rate (GFR) greater than 30 mL/min within 90 days before registration
- Total bilirubin less than or equal to 3 times the upper limit of normal within 90 days before registration
- Albumin greater than 30 g/L within 90 days before registration
- White blood cell count at least 2,000 cells/mm3 within 90 days before registration
- Platelets at least 70,000 cells/mm3 within 90 days before registration
- Hemoglobin at least 8.0 g/dL (transfusion allowed to reach this level) within 90 days before registration
You will not qualify if you...
- Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site or region
- Contraindications to radiation therapy such as inflammatory bowel disease or systemic sclerosis
- Brain metastases or metastases extending into the spinal canal
- Unable to confirm payment coverage for planned radiation treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
P
Pretesh Patel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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