Double radiation attack may slow tough gut tumors
NCT ID NCT07150546
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether adding focused external radiation (SBRT) before a standard radioactive drug therapy (177Lu-DOTATATE) is safe and effective for people with large, inoperable neuroendocrine tumors of the digestive system. About 15 adults whose tumors have grown despite prior treatment will receive both therapies. The goal is to see if the combination can better control the disease than the drug alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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