Spanish Series of Patients Treated With the Radionuclide Lutetium177 (SEPTRALU)

December 22, 2022 updated by: Sociedad Española de Medicina Nuclear e Imagen Molecular

SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Burgos, Spain, 09006
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario De Ciudad Real
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
      • Pamplona, Spain, 31008
      • Valencia, Spain, 46026
      • Valencia, Spain, 46017
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario De Santiago
        • Contact:
    • Andalucia
      • Granada, Andalucia, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Not yet recruiting
        • Hospital Universitario de Getafe
        • Contact:
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Univeritario Puerta de Hierro
        • Contact:
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Contact:
    • Navarra
      • Pamplona, Navarra, Spain, 31008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lutathera
Drug: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Names:
  • Lutathera
Device: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Names:
  • Lutathera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
Up to 12 months
Overall survival (OS)
Time Frame: Up to 12 months
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)
Time Frame: 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
Up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Medicina Nuclear e Imagen Molecular

Investigators

  • Principal Investigator: Mercedes Dr Mitjavila Casanovas, MD-PhD, Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Anticipated)

December 31, 2034

Study Completion (Anticipated)

December 31, 2035

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEM-LUT-2020-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digestive System Diseases

Clinical Trials on Lutetium [177Lu] oxodotreotide/dotatate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe