Stereotactic radiation followed by PRRT for large digestive neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I study gives stereotactic body radiation therapy (SBRT) over five fractions to patients with large, well‑differentiated grade 1–2 digestive system neuroendocrine tumors, followed 4–10 weeks later by standard‑dose 177Lu‑DOTATATE every 8 weeks for four doses. Patients must have somatostatin‑receptor positive disease and at least one lesion ≥3 cm. The primary goal is to measure acute grade 3 or higher non‑hematologic toxicity of the combined approach compared with historical PRRT alone; secondary endpoints include grade 2+ toxicity, lesion response at 3 months, progression‑free survival, and patient‑reported toxicity. Imaging with CT, MRI and Ga‑68 DOTATATE PET/CT is used for staging and response assessment, and participants are followed for clinical outcomes and PROs for at least 12 months after treatment.

Why it matters

Who can join: the full rules

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 it's running

• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Pretesh Patel, MD — Emory University
• Study coordinator: Pretesh Patel, MD
• Email: pretesh.patel@emory.edu
• Phone: 404-778-3473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.