Digestive System Neuroendocrine TumorPhase 1NCT07150546
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
A Phase 1 study testing Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate and Computed Tomography in people with Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Neoplasm, run by Emory University at 2 sites in United States.
Trial 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 large well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1
- What is being tested?
- Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2025to 30 Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Lisa Metzger, lisa.metzger@emory.edu
Pretesh Patel, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Lisa Metzger, lisa.metzger@emory.edu
Pretesh Patel, MD
About this study
Official title: Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To determine the rate of acute grade 2+ toxicity compared to historical control of PRRT alone.
II. To determine response rate of both large and small lesions at 3 months following treatment.
III. To determine progression free survival. IV. To describe patient-reported outcomes (PROs) of toxicity.
OUTLINE:
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive standard of care (SOC) lutetium-177 DOTATATE (177Lu-DOTATATE) intravenously (IV) once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial and undergo gallium Ga 68-DOTATATE positron emission tomography (PET)/CT before treatment.
After completion of study treatment, patients are followed up at 90 days and then every 3 months for 12 months.
- Conditions
- Digestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1, Unresectable Digestive System Neuroendocrine Tumor G2
- Being tested
- Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate, Computed Tomography, Magnetic Resonance Imaging, Gallium Ga 68-DOTATATE
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy
Undergo SBRT
Lutetium Lu 177 DotatateDrug
Also called 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 437608-50-9, Lutathera, Lutetium (177Lu) Oxodotreotide, 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium (177Lu) Oxodotreotide, Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate, Lutetium Lu 177 Dotatate, Lutetium Lu 177-DOTA-Tyr3-Octreotate,Lutetium Oxodotreotide Lu-177
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, Computed Tomography, Computed Tomography, computed tomography, Computed Tomography, computerized axial tomography,, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, computerized tomography, Computerized Tomography,, Computerized Tomography (CT) scan, CT, CT, CT, CT, CT SCAN, CT Scan, CT scan, CT Scan, CT Scan, CT Scan, CT Scan, tomography
Undergo CT and PET/CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR,MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo MRI
Gallium Ga 68-DOTATATERadiation
Also called (68)Ga-DOTA-TATE, 1027785-90-5, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide, GALLIUM OXODOTREOTIDE GA-68, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Undergo gallium Ga 68-DOTATATE PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET, Pet Scan, PET SCAN, PET scan, PET Scan, PET Scan, PET Scan, Positron Emission Tomography, Positron Emission Tomography,, Positron emission tomography (procedure), positron emission tomography scan, Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT, 177Lu-DOTATATE) | Experimental | Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment. Receives: Radiation: Stereotactic Body Radiation Therapy; Drug: Lutetium Lu 177 Dotatate; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Radiation: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months of therapy
Secondary outcomes (4)
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.
Measured: Up to 12 months
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.
Measured: At 3 months
Progression Free Survival
Progression free survival at 12 months will be estimated with the Kaplan-Meier method along with 95% confidence intervals.
Measured: At 12 months
Patient-Reported Health-Related Quality of Life
Patient reported outcome will be summarized as mean, median, first quartile, third quartile, and standard deviation.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start14 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Pretesh Patel, Emory University
- Investigators
- Pretesh Patel, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150546
- Sponsor's protocol ID
- STUDY00008681
- Other IDs
- P30CA138292, NCI-2025-05882, STUDY00008681, RAD6422-24
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No