Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

Conditions

• Digestive System Neuroendocrine Tumor
• Unresectable Digestive System Neuroendocrine Neoplasm
• Unresectable Digestive System Neuroendocrine Tumor G1
• Unresectable Digestive System Neuroendocrine Tumor G2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT
• Lutetium Lu 177 Dotatate — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT and PET/CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Gallium Ga 68-DOTATATE — RADIATION
  Undergo gallium Ga 68-DOTATATE PET/CT
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Oct 14, 2025

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Incidence of Acute Grade 3+ Non-Hematologic Adverse Events [ Time Frame: Within 3 months of therapy ]

Central Contacts

• Pretesh Patel, MD
  404-778-3473
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

Related Studies

• Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama