Status:
NOT_YET_RECRUITING
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Digestive System Neuroendocrine Tumor
Unresectable Digestive System Neuroendocrine Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 la...
Detailed 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 det...
Eligibility Criteria
Inclusion
- 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 contrast-enhanced CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Estimated glomerular filtration rate (GFR) \> 30 mL/min (within 90 days prior to study registration)
- Total bilirubin ≤ 3 x upper limit of normal (within 90 days prior to study registration)
- Albumin \> 30 g/L (within 90 days prior to study registration)
- White blood cell (WBC) ≥ 2,000 cells/mm\^3 (within 90 days prior to study registration)
- Platelets ≥ 70000 cells/mm\^3 (within 90 days prior to study registration)
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable.) (within 90 days prior to study registration)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07150546
Start Date
September 1 2025
End Date
September 30 2026
Last Update
September 2 2025
Active Locations (2)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital
Atlanta, Georgia, United States, 30322