Clinical trial · Observational
Spanish Series of Patients Treated With the Radionuclide Lutetium177
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
NCT04949282CI-TRIAL-00062859SEPTRALUrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Diseases | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endocrine Gland Neoplasms | — | UNRESOLVED | — |
| Endocrine System Diseases | — | UNRESOLVED | — |
| Gastrointestinal Disease | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Intestinal Diseases | — | UNRESOLVED | — |
| Intestinal Neoplasms | Intestinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutetium [177Lu] oxodotreotide/dotatate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lutathera
- interventionNames
- Drug: Lutetium [177Lu] oxodotreotide/dotatate
- Device: Lutetium [177Lu] oxodotreotide/dotatate
Primary outcomes (3)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Up to 12 months
- description
- 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.
- measure
- Overall survival (OS)
- timeFrame
- Up to 12 months
- description
- Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMitjavila 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 36877234