Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
NCT ID: NCT07150546
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-09-01
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
NCT04609592
Efficacy and Safety of 177Lu-Dotatate PRRT in Metastatic GEP-NEN Patients
NCT03422029
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
NCT04090034
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
NCT03273712
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
NCT00589121
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (SBRT, 177Lu-DOTATATE)
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.
Stereotactic Body Radiation Therapy
Undergo SBRT
Lutetium Lu 177 Dotatate
Given IV
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Gallium Ga 68-DOTATATE
Undergo gallium Ga 68-DOTATATE PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stereotactic Body Radiation Therapy
Undergo SBRT
Lutetium Lu 177 Dotatate
Given IV
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Gallium Ga 68-DOTATATE
Undergo gallium Ga 68-DOTATATE PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pretesh Patel
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pretesh Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2025-05882
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00008681
Identifier Type: OTHER
Identifier Source: secondary_id
RAD6422-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00008681
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.