Digestive System Diseases, Digestive System Neoplasms, Endocrine Gland Neoplasms, Endocrine System Diseases, Gastrointestinal Disease, Gastrointestinal Neoplasms, Intestinal Diseases, Intestinal Neoplasms, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue, Neuroectodermal Tumors, Neuroendocrine Tumors, Pancreatic Disease, Pancreatic Neoplasms, Stomach Neoplasms
Conditions
Keywords
GEP-NET, Gastro-Entero-Pancreatic Neuroendocrine Tumour, Luthatera, Somatostatin receptor positive tumour
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.
Interventions
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Sponsors
Sociedad Española de Medicina Nuclear e Imagen Molecular
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 12 months | 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. |
| Overall survival (OS) | Up to 12 months | Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause. |
| Overall response rate (ORR) | Up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Areas for improvement care | Up to 12 months | Identification of areas for improvement in the management and selection of patients for treatment with lutathera |
| Characteristics of the population . | Up to 12 months | Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution. |
| Health-related Quality of Life (HRQoL) | Up to 12 months | 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. |
| Adverse Events (AEs) | Up to 12 months | Toxicity will be collected according to grades (NCT-CTCAE) and consequences. |
| Prognostic factors | Up to 12 months | Correlation of possible prognostic factors with clinical effectiveness outcomes. |
Countries
Spain
Contacts
Primary ContactMercedes Dr Mitjavila Casanovas, MD-PhD
Backup ContactPaula Dr Jiménez Fonseca, MD-PhD
Outcome results
None listed