Spanish Series of Patients Treated With the Radionuclide Lutetium177
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lutetium [177Lu] oxodotreotide/dotatate, Lutetium [177Lu] oxodotreotide/dotatate.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
Overview
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.
Detailed description
Patient data will be collected from medical records after obtaining consent and retrospectively.
Interventions
- Drug Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) - Device Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: Up to 12 months]
- Overall survival (OS) [Time frame: Up to 12 months]
- Overall response rate (ORR) [Time frame: Up to 12 months]
Secondary outcome measures (5)
- Characteristics of the population . [Time frame: Up to 12 months]
- Adverse Events (AEs) [Time frame: Up to 12 months]
- Prognostic factors [Time frame: Up to 12 months]
- Areas for improvement care [Time frame: Up to 12 months]
- Health-related Quality of Life (HRQoL) [Time frame: Up to 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 20 centers
- Hospital Clínico Universitario de Santiago — Santiago de Compostela
- Hospital Universitario Virgen de las Nieves — Granada
- Hospital Unviersitari Son Espases — Palma de Mallorca
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Hospital Universitario de Getafe — Getafe
- Hospital Univeritario Puerta de Hierro — Majadahonda
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar
- Clínica Universidad de Navarra — Pamplona
- … and 12 more centers
Publications
- 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 l PMID 36877234
Identifiers
NCT: NCT04949282 · SEM-LUT-2020-01