Spanish Series of Patients Treated With the Radionuclide Lutetium177

Neoplasms Clinical Trial

— SEPTRALU  

Official title:

SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949282
• Other study ID #: SEM-LUT-2020-01
• Status: Recruiting
• Start date: May 10, 2021
• Est. completion date: December 31, 2035

Study information

• Verified date: December 2022
• Source: Sociedad Española de Medicina Nuclear e Imagen Molecular
• Contact: Mercedes Dr Mitjavila Casanovas, MD-PhD
• Phone: 911916000
• Email: mercedes.mitjavila[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Digestive System Neoplasms
• Endocrine Gland Neoplasms
• Endocrine System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasms
• Neoplasms by Histologic Type
• Neoplasms by Site
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Nerve Tissue
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroendocrine Tumors
• Pancreatic Disease
• Pancreatic Diseases
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Device:
• Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucia
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Univeritario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Unviersitari Son Espases	Palma De Mallorca	Islas Baleares
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Medicina Nuclear e Imagen Molecular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Adverse Events (AEs)	Toxicity will be collected according to grades (NCT-CTCAE) and consequences.	Up to 12 months
Secondary	Prognostic factors	Correlation of possible prognostic factors with clinical effectiveness outcomes.	Up to 12 months
Secondary	Areas for improvement care	Identification of areas for improvement in the management and selection of patients for treatment with lutathera	Up to 12 months
Secondary	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