NCT07150546 · Emory University
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
What this study is about
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).
View original scientific description
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.
Interventions
RADIATION
Stereotactic Body Radiation Therapy
Undergo SBRT
DRUG
Lutetium Lu 177 Dotatate
Given IV
PROCEDURE
Computed Tomography
Undergo CT and PET/CT
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
RADIATION
Gallium Ga 68-DOTATATE
Undergo gallium Ga 68-DOTATATE PET/CT
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
Time frame: Within 3 months of therapy
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations