Clinical trial · Interventional
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
| Unresectable Digestive System Neuroendocrine Neoplasm | Digestive System Neuroendocrine Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Digestive System Neuroendocrine Tumor G1 | Digestive System Neuroendocrine Tumor G1 | CURATED_BROADER | 0.78 |
| Unresectable Digestive System Neuroendocrine Tumor G2 | Digestive System Neuroendocrine Tumor G2 | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68-DOTATATE | Radiation | — | UNRESOLVED |
| Lutetium Lu 177 Dotatate | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT, 177Lu-DOTATATE)
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
- timeFrame
- Within 3 months of therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available