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Spanish Series of Patients Treated With the Radionuclide Lutetium177 (SEPTRALU)

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ClinicalTrials.gov Identifier: NCT04949282
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
Sociedad Española de Medicina Nuclear e Imagen Molecular

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Intestinal Neoplasms Pancreatic Neoplasms Stomach Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Gastrointestinal Disease Intestinal Diseases Pancreatic Disease Endocrine System Diseases Drug: Lutetium [177Lu] oxodotreotide/dotatate Device: Lutetium [177Lu] oxodotreotide/dotatate

Detailed Description:
Patient data will be collected from medical records after obtaining consent and retrospectively.
Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 31, 2034
Estimated Study Completion Date : December 31, 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Lutathera Drug: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Name: Lutathera

Device: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Name: Lutathera


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949282


Contacts
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Contact: Mercedes Dr Mitjavila Casanovas, MD-PhD 911916000 ext 46261 mercedes.mitjavila@salud.madrid.org
Contact: Paula Dr Jiménez Fonseca, MD-PhD 985106121 ext 36582 palucaji@hotmail.com

Locations
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Sponsors and Collaborators
Sociedad Española de Medicina Nuclear e Imagen Molecular
Investigators
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Principal Investigator: Mercedes Dr Mitjavila Casanovas, MD-PhD Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
More Information
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Responsible Party: Sociedad Española de Medicina Nuclear e Imagen Molecular
ClinicalTrials.gov Identifier: NCT04949282    
Other Study ID Numbers: SEM-LUT-2020-01
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sociedad Española de Medicina Nuclear e Imagen Molecular:
GEP-NET
Gastro-Entero-Pancreatic Neuroendocrine Tumour
Luthatera
Somatostatin receptor positive tumour
Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Pancreatic Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Intestinal Neoplasms
Endocrine Gland Neoplasms
Neoplasms, Germ Cell and Embryonal
 Neoplasms, Nerve Tissue
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Intestinal Diseases
Endocrine System Diseases
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Stomach Diseases
Lutetium Lu 177 dotatate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action