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Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
NCT05773274 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu-DOTATATE may work better than everolimus, sunitinib or cabozantinib in shrinking or stabilizing tumors in patients with metastatic and unresectable GEPNET who were previously treated with 177Lu-DOTATATE.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Everolimus
- DRUG Cabozantinib
- DRUG Lutetium Lu 177 Dotatate
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- Mayo Clinic in Florida — Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
Illinois
- Northwestern University — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb
- Northwestern Medicine Cancer Center Delnor — Geneva
- UC Comprehensive Cancer Center at Silver Cross — New Lenox
- University of Chicago Medicine-Orland Park — Orland Park
- Northwestern Medicine Cancer Center Warrenville — Warrenville
Arizona
- Mayo Clinic Hospital in Arizona — Phoenix
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Colorado
- UCHealth University of Colorado Hospital — Aurora
Iowa
- Iowa Methodist Medical Center — Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05773274
The ClinicalTrials.gov registry entry for NCT05773274 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Unresectable Digestive System Neuroendocrine Tumor G1 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05773274 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05773274 about?
NCT05773274 is a clinical study titled "Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial". This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tum...
What is the current status of trial NCT05773274?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-01-12. Estimated completion is 2026-04-30.
What conditions does trial NCT05773274 study?
This clinical trial studies the following conditions: Unresectable Digestive System Neuroendocrine Tumor G1, Unresectable Digestive System Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05773274?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Everolimus (DRUG), Cabozantinib (DRUG), Lutetium Lu 177 Dotatate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05773274?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05773274 being conducted?
This trial has 20 study locations across Alabama, Arizona, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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