Clinical trial NCT04949282: Spanish Series of Patients Treated With the Radionuclide Lutetium177
Official title: SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: GEP-NET
Gastro-Entero-Pancreatic Neuroendocrine Tumour
Luthatera
Somatostatin receptor positive tumour
Lead sponsor: Sociedad Española de Medicina Nuclear e Imagen Molecular
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.

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.

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

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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 12 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
measure: Overall response rate (ORR)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Characteristics of the population .
timeFrame: Up to 12 months
measure: Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Prognostic factors
timeFrame: Up to 12 months
measure: Areas for improvement care
timeFrame: Up to 12 months
measure: Health-related Quality of Life (HRQoL)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A Coruña
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Palma De Mallorca
country: Spain
facility: Hospital Unviersitari Son Espases
state: Islas Baleares
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Univeritario Puerta de Hierro
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
name: Mercedes Dr Mitjavila Casanovas, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: