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Completed

NCT Number: NCT05816720

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77042, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • <18 years of age

Treatment and study plan

Lutetium-177 DOTATATE

Drug

Intravenous administration

Other names: Lutathera®

Primary outcomes

  1. Progression-free survival

    Time frame: Up to approximately 11 years

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

  2. Overall survival

    Time frame: Up to approximately 11 years

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

  3. Percentage of patients with treatment response

    Time frame: Up to approximately 11 years

    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)

Secondary outcomes

  1. Number of patients with adverse events (AEs)

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

  3. Mean change from baseline in hemoglobin

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

  5. Mean change from baseline in lymphocyte count

    Time frame: Up to approximately 11 years

  6. Mean change from baseline in platelet count

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

  10. Mean change from baseline in albumin

    Time frame: Up to approximately 11 years

  11. Mean change from baseline in bilirubin

    Time frame: Up to approximately 11 years

  12. Mean change from baseline in creatinine

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

  14. Mean change from baseline in cromogranin A

    Time frame: Up to approximately 11 years

  15. Mean change from baseline in pancreatic polypeptide

    Time frame: Up to approximately 11 years

  16. Mean change from baseline in pancreastatin

    Time frame: Up to approximately 11 years

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

    Time frame: Prior to initial treatment with lutetium-177 DOTATATE

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

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

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

    Time frame: Up to approximately 11 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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