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NCT Number: NCT04949282

Spanish Series of Patients Treated With the Radionuclide Lutetium177

This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.

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Key information

Conditions

Neuroendocrine Tumors Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastro-enteropancreatic neuroendocrine tumor Gastrointestinal Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Pancreatic Disease Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

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About this study

Patient data will be collected from medical records after obtaining consent and retrospectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent must be obtained prior to any data collection.
  • Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour
  • Aged ≥18 years.

Exclusion criteria

  • None

Treatment and study plan

Lutetium [177Lu] oxodotreotide/dotatate

Drug

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Other names: Lutathera

Lutetium [177Lu] oxodotreotide/dotatate

Device

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Other names: Lutathera

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to 12 months

    Defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.

  2. Overall survival (OS)

    Time frame: Up to 12 months

    Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.

  3. Overall response rate (ORR)

    Time frame: Up to 12 months

    Is determined by imaging technique according to RECIST criteria v1.1 and is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1

Secondary outcomes

  1. Characteristics of the population .

    Time frame: Up to 12 months

    Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.

  2. Adverse Events (AEs)

    Time frame: Up to 12 months

    Toxicity will be collected according to grades (NCT-CTCAE) and consequences.

  3. Prognostic factors

    Time frame: Up to 12 months

    Correlation of possible prognostic factors with clinical effectiveness outcomes.

  4. Areas for improvement care

    Time frame: Up to 12 months

    Identification of areas for improvement in the management and selection of patients for treatment with lutathera

  5. Health-related Quality of Life (HRQoL)

    Time frame: Up to 12 months

    Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire.The minimum value ( 1%) and the maximum value (100%), and higher scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Mercedes Dr Mitjavila Casanovas, MD-PhD

CONTACT

[email protected]

911916000 ext. 46261

Paula Dr Jiménez Fonseca, MD-PhD

CONTACT

[email protected]

985106121 ext. 36582

Sponsors and collaborators

Lead sponsor

Sociedad Española de Medicina Nuclear e Imagen Molecular

Other

Registry information

Official study title

SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

Acronym: SEPTRALU

Important dates

Study start
2021
Primary completion
2034
Study completion
2035
First posted
Jul 2, 2021
Registry last updated
Dec 23, 2022

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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