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.
Patient data will be collected from medical records after obtaining consent and retrospectively.
Study Type
OBSERVATIONAL
Enrollment
5,000
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
RECRUITINGHospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
RECRUITINGHospital Unviersitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGHospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario de Getafe
Getafe, Madrid, Spain
NOT_YET_RECRUITINGHospital Univeritario Puerta de Hierro
Majadahonda, Madrid, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
RECRUITINGClínica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Spain
NOT_YET_RECRUITING...and 10 more locations
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.
Time frame: 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.
Time frame: 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
Time frame: Up to 12 months
Characteristics of the population .
Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.
Time frame: Up to 12 months
Adverse Events (AEs)
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
Time frame: Up to 12 months
Prognostic factors
Correlation of possible prognostic factors with clinical effectiveness outcomes.
Time frame: Up to 12 months
Areas for improvement care
Identification of areas for improvement in the management and selection of patients for treatment with lutathera
Time frame: Up to 12 months
Health-related Quality of Life (HRQoL)
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.
Time frame: Up to 12 months
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