Spanish Series of Patients Treated With the Radionuclide Lutetium177

Study Overview
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Brief Summary
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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
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Patient data will be collected from medical records after obtaining consent and retrospectively.

Official Title
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SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

Conditions
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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

Intervention / Treatment
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* Drug: Lutetium [177Lu] oxodotreotide/dotatate
* Device: Lutetium [177Lu] oxodotreotide/dotatate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lutathera<br> | Drug: Lutetium [177Lu] oxodotreotide/dotatate<br>* Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)<br>* Other names: Lutathera;Device: Lutetium [177Lu] oxodotreotide/dotatate<br>* Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)<br>* Other names: Lutathera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of the population . | Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution. | Up to 12 months | 
| Adverse Events (AEs) | Toxicity will be collected according to grades (NCT-CTCAE) and consequences. | Up to 12 months | 
| Prognostic factors | Correlation of possible prognostic factors with clinical effectiveness outcomes. | Up to 12 months | 
| Areas for improvement care | Identification of areas for improvement in the management and selection of patients for treatment with lutathera | 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. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GEP-NET, Gastro-Entero-Pancreatic Neuroendocrine Tumour, Luthatera, Somatostatin receptor positive tumour