Actively Recruiting
Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors A Single Arm Pilot Clinical Trial
Led by Emory University · Updated on 2026-03-02
15
Participants Needed
2
Research Sites
52 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
Researchers are studying a combination treatment for patients with large, well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery. This phase I trial evaluates the safety and effects of stereotactic body radiation therapy SBRT followed by lutetium-177 DOTATATE peptide receptor radionuclide therapy PRRT. The study aims to compare this combination approach to the standard use of PRRT alone in hopes of reducing disease progression or recurrence. Participants first receive SBRT over 5 treatment sessions to precisely target tumors while sparing healthy tissue. Then, 4 to 10 weeks later, they receive standard care 177Lu-DOTATATE through intravenous infusions every 8 weeks for a total of 4 doses, provided there is no disease progression or unacceptable side effects. Imaging scans including CT, MRI, and gallium Ga 68-DOTATATE PETCT are performed before and during treatment to monitor the tumor. During the trial, patients are closely monitored for side effects and tumor response. Follow-up visits occur at 90 days after treatment and then every 3 months for a year. Researchers measure acute toxicity within 3 months, tumor response at 3 months, progression-free survival at 12 months, and patient-reported quality of life up to 12 months. These assessments involve scans, questionnaires, and clinical evaluations to understand treatment safety and impact.
CONDITIONS
Brief 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 study specific informed consent
- Pathologically confirmed well-differentiated grade 1-2 neuroendocrine tumor
- Unresectable tumor confirmed by tumor board or surgical oncology
- Progression after one or two prior lines of systemic therapy
- Somatostatin-receptor positive disease by DOTATATE PET/CT scan (modified Krenning score 3+)
- One or more large lesions measuring 3 or more cm on contrast-enhanced CT or MRI
- ECOG performance status 0-2
- Estimated glomerular filtration rate (GFR) greater than 30 mL/min within 90 days prior to registration
- Total bilirubin less than or equal to 3 times upper limit of normal within 90 days prior to registration
- Albumin greater than 30 g/L within 90 days prior to registration
- White blood cell count 2,000 cells/mm3 or higher within 90 days prior to registration
- Platelet count 70,000 cells/mm3 or higher within 90 days prior to registration
- Hemoglobin 8.0 g/dl or higher (transfusion or intervention acceptable) within 90 days prior to registration
You will not qualify if you...
- Prior radiation therapy including PRRT, external radiation, or Yttrium-90 radioembolization to the same site/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
Research Team
P
Pretesh Patel, MD
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