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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04949282
Other study ID # SEM-LUT-2020-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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