Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. (NCT07150546) | Clinical Trial Compass
RecruitingPhase 1
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
United States15 participantsStarted 2025-10-14
Plain-language 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 (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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Acute Grade 3+ Non-Hematologic Adverse Events