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Digestive System Neuroendocrine Tumor G1Phase 4NCT06016855

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

A Phase 4 study testing Tumor Debulking, Lutetium Lu 177 Dotatate and Computed Tomography in people with Digestive System Neuroendocrine Tumor G1 and Digestive System Neuroendocrine Tumor G2, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tumor Debulking, Lutetium Lu 177 Dotatate and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
31 May 2024to 28 May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent
  • Male or female >= 18 years of age on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =< 20%)
  • Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan performed within 6 months (180 days) prior to surgical debulking on study day 0. The somatostatin receptor avidity of the majority of suspected NET lesion(s) must be >= normal liver uptake
  • Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease
Show all 15Show fewer
  • White blood cell count (WBC) >= 2000/uL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Platelets >= 75,000/uL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Hemoglobin >= 8.0 g/dL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Creatinine clearance (CrCl) >= 30 mL/minute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate [eCCR] >= 30 mL/min required for eligibility inclusion; or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Total bilirubin =< 3.0 times institutional upper limit of normal (ULN) (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Serum albumin >= 3.0 g/dL unless the prothrombin time is within normal range (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate
  • A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until 7 months after her final dose of lutetium Lu 177 dotatate
  • A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of lutetium Lu 177 dotatate

Who cannot join

  • Patient has any tumor > 3 cm deemed to be inoperable
  • Patient has disease which is considered to be completely surgically resectable
  • Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)
  • Prior receipt of peptide receptor radionuclide therapy (PRRT)
  • Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)
  • Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia
  • Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's completion of the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanderbilt-Ingram Services for Timely Access contact

800-811-8480

cip@vumc.org

United States1 site, 1 recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37203

    Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org

    Kamran Idrees, MD

    Recruiting

Other trials in United States

About this study

Official title: Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs

Read the detailed description

PRIMARY OBJECTIVES:

  1. To measure objective response rate of a combination standard of care treatment in gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90 days of surgical debulking.

II. To assess the radiomic profile including somatostatin receptor standardized uptake values (SSTR SUV) of large and non-large tumors in study patients)

III: To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT) post-surgical debulking in patients on study.

IV. To assess the tumor genomic profile of large, resected tumors from patients and assess for signatures of radioresistance.

OUTLINE:

Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate (177Lu dotatate) intravenously (IV) over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial, and undergo copper Cu 64 dotatate positron emission tomography/CT (dotatate PET/CT) during screening and on study.

After completion of study treatment, patients are followed up at 30-37 days after last dose and then every 3 months for 2 years.

Being tested
Tumor Debulking, Lutetium Lu 177 Dotatate, Computed Tomography, Magnetic Resonance Imaging, Copper Cu 64 Dotatate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor DebulkingProcedure or surgery

    Undergo surgical debulking

  • Lutetium Lu 177 DotatateDrug

    Given by IV

  • Computed TomographyProcedure or surgery

    Undergo Computed Tomography

  • Magnetic Resonance ImagingProcedure or surgery

    Undergo Magnetic Resonance Imaging

  • Copper Cu 64 DotatateDrug

    Given by IV

  • Positron Emission TomographyProcedure or surgery

    Undergo Positron Emission Tomography

Study groups in NCT06016855
Study groupRoleWhat they receive
Treatment (surgical debulking, 177Lu dotatate)ExperimentalPatients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.
Receives: Procedure: Tumor Debulking; Drug: Lutetium Lu 177 Dotatate; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Copper Cu 64 Dotatate; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Somatostatin receptor standardized uptake values (SSTR SUV)

    SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.

    Measured: Up to 2 years

  2. Progression-free survival

    Will be estimated by the Kaplan-Meier method.

    Measured: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years

  3. Overall response rate

    Will be estimated by measuring the number of patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria on restaging computed tomography or magnetic resonance imaging scans =< 6 months from PRRT completion, from the total number of patients who received the study treatment and possessed measurable disease post-surgical debulking. The number of patients who possessed measurable disease which did not meet RECIST 1.1 eligibility criteria post-surgical debulking will also be recorded.

    Measured: Up to 2 years

  4. Overall survival

    Will be estimated by the Kaplan-Meier method.

    Measured: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years

  5. Incidence of adverse events

    Toxicity will be estimated by documenting the grade 3/4 adverse events, according to Common Terminology Criteria for Adverse Events version 5.0, experienced by study patients.

    Measured: Up to 2 years

  6. Gene mutations

    Mutations in genes associated with radioresistance (defined from other malignancies) and other mutations in large resected neuroendocrine tumors will be recorded. Mutations will be described descriptively.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start31 May 2024
  3. Primary completion28 May 2027 (estimated)
  4. Study completion28 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06016855
Sponsor's protocol ID
VICCGI2283
Other IDs
NCI-2023-05914
Status last verified
May 2026
First submitted
23 Aug 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • von Hessert-Vaudoncourt C, Maasberg S, Begum N, Rinke A, Poppel T, Sipos B, Grohe C, Fottner C, Stintzing S, Grabowski P; German NET Registry. Clinical characteristics and treatment patterns of patients with gastroenteropancreatic neuroendocrine neoplasia in Germany receiving peptide receptor radionuclide therapy: A real-world data registry-based study. Medicine (Baltimore). 2025 Mar 14;104(11):e41853. doi: 10.1097/MD.0000000000041853.

    PubMed 40101049

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tumor Debulking, Lutetium Lu 177 Dotatate and Computed Tomography in people with Digestive System Neuroendocrine Tumor G1 and Digestive System Neuroendocrine Tumor G2, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Somatostatin receptor standardized uptake values (SSTR SUV) (time frame: Up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06016855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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