Spanish Series of Patients Treated With the Radionuclide Lutetium177
SEPTRALU
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
1 other identifier
observational
5,000
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2021
CompletedFirst Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
December 23, 2022
December 1, 2022
13.7 years
June 14, 2021
December 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Progression Free Survival (PFS)
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.
Up to 12 months
Overall survival (OS)
Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Up to 12 months
Overall response rate (ORR)
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
Up to 12 months
Secondary Outcomes (5)
Characteristics of the population .
Up to 12 months
Adverse Events (AEs)
Up to 12 months
Prognostic factors
Up to 12 months
Areas for improvement care
Up to 12 months
Health-related Quality of Life (HRQoL)
Up to 12 months
Study Arms (1)
Lutathera
Interventions
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Eligibility Criteria
The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014, Spain
Hospital Unviersitari Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Hospital Univeritario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitario La Fe
Valencia, 46026, Spain
Related Publications (1)
Mitjavila M, Jimenez-Fonseca P, Bello P, Pubul V, Percovich JC, Garcia-Burillo A, Hernando J, Arbizu J, Rodeno E, Estorch M, Llana B, Castellon M, Garcia-Canamaque L, Gajate P, Riesco MC, Miguel MB, Balaguer-Munoz D, Custodio A, Cano JM, Repetto A, Garcia-Alonso P, Muros MA, Vercher-Conejero JL, Carmona-Bayonas A. Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(8):2486-2500. doi: 10.1007/s00259-023-06166-8. Epub 2023 Mar 6.
PMID: 36877234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mercedes Dr Mitjavila Casanovas, MD-PhD
Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2021
First Posted
July 2, 2021
Study Start
May 10, 2021
Primary Completion (Estimated)
December 31, 2034
Study Completion (Estimated)
December 31, 2035
Last Updated
December 23, 2022
Record last verified: 2022-12