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Neuroendocrine TumorNCT05816720

Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

An observational study of Neuroendocrine Tumor, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \& Nuclear Oncology Center in Houston, Texas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumor
What is being tested?
Lutetium-177 DOTATATE
Type of treatment
Injection or infusion
How many people
31 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 31 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

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

Study population: This was a retrospective, noninterventional cohort study

Who may be able to join

  • Diagnosis of any NET
  • Evidence of re-treatment with lutetium-177 DOTATATE
  • Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE
  • Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose

Who cannot join

  • <18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Excel Diagnostics & Nuclear Oncology Center

    Houston, Texas, 77042

Other trials in United States

About this study

This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \& Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.

The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):

  1. Date of death - the date at which a patient was reported in the database as having died
  2. Last month active - the last recorded mention of the patient in the dataset
  3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.
Being tested
Lutetium-177 DOTATATE
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • Lutetium-177 DOTATATEDrug

    Also called Lutathera®

    Intravenous administration

Study groups in NCT05816720
Study groupRoleWhat they receive
Initial treatmentPatients who received initial treatment with lutetium-177 DOTATATE
Receives: Drug: Lutetium-177 DOTATATE
Re-treatmentPatients who received re-treatment with lutetium-177 DOTATATE
Receives: Drug: Lutetium-177 DOTATATE
Additional re-treatmentPatients who received additional re-treatment with lutetium-177 DOTATATE
Receives: Drug: Lutetium-177 DOTATATE

What is being measured

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

  1. Progression-free survival

    Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death

    Measured: Up to approximately 11 years

  2. Overall survival

    Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death

    Measured: Up to approximately 11 years

  3. Percentage of patients with treatment response

    Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD)

    Measured: Up to approximately 11 years

Secondary outcomes (20)

  1. Number of patients with adverse events (AEs)

    Measured: Up to approximately 11 years

  2. Mean change from baseline in white blood cell (WBC) count

    Measured: Up to approximately 11 years

  3. Mean change from baseline in hemoglobin

    Measured: Up to approximately 11 years

  4. Mean change from baseline in absolute neutrophil count (ANC)

    Measured: Up to approximately 11 years

  5. Mean change from baseline in lymphocyte count

    Measured: Up to approximately 11 years

  6. Mean change from baseline in platelet count

    Measured: Up to approximately 11 years

  7. Mean change from baseline in alkaline phosphatase (ALP)

    Measured: Up to approximately 11 years

  8. Mean change from baseline in alanine aminotransferase (ALT)

    Measured: Up to approximately 11 years

  9. Mean change from baseline in aspartate aminotransferase (AST)

    Measured: Up to approximately 11 years

  10. Mean change from baseline in albumin

    Measured: Up to approximately 11 years

  11. Mean change from baseline in bilirubin

    Measured: Up to approximately 11 years

  12. Mean change from baseline in creatinine

    Measured: Up to approximately 11 years

  13. Mean change from baseline in estimated glomerular filtration rate (eGFR)

    Measured: Up to approximately 11 years

  14. Mean change from baseline in cromogranin A

    Measured: Up to approximately 11 years

  15. Mean change from baseline in pancreatic polypeptide

    Measured: Up to approximately 11 years

  16. Mean change from baseline in pancreastatin

    Measured: Up to approximately 11 years

  17. Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE

    Measured: Prior to initial treatment with lutetium-177 DOTATATE

  18. Number of patients who received lutetium-177 DOTATATE, categorized by number of doses

    Measured: Up to approximately 11 years

  19. Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage

    Measured: Up to approximately 11 years

  20. Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage

    Measured: Up to approximately 11 years

Timeline

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

  1. First posted18 Apr 2023
  2. Study start1 Sep 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816720
Sponsor's protocol ID
CAAA601A1US08
Status last verified
Apr 2023
First submitted
30 Jan 2023
Last updated
18 Apr 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Tumor, run by Novartis Pharmaceuticals 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Apr 2023. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to approximately 11 years). The study lists 3 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 NCT05816720.

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 18 Apr 2023.

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