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Spanish Series of Patients Treated With the Radionuclide Lutetium177

ConditionsNeuroendocrine TumorsIntestinal NeoplasmsPancreatic NeoplasmsStomach NeoplasmsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesGastrointestinal DiseaseIntestinal DiseasesPancreatic DiseaseEndocrine System Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSociedad Española de Medicina Nuclear e Imagen Molecular

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • Lutetium [177Lu] oxodotreotide/dotatate

    Drug

    Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

  • Lutetium [177Lu] oxodotreotide/dotatate

    Device

    Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Lutathera2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 months
2

Overall survival (OS)

Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.

Time frame
Up to 12 months
3

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

Time frame
Up to 12 months

Secondary outcomes

1

Characteristics of the population .

Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.

Time frame
Up to 12 months
2

Adverse Events (AEs)

Toxicity will be collected according to grades (NCT-CTCAE) and consequences.

Time frame
Up to 12 months
3

Prognostic factors

Correlation of possible prognostic factors with clinical effectiveness outcomes.

Time frame
Up to 12 months
4

Areas for improvement care

Identification of areas for improvement in the management and selection of patients for treatment with lutathera

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sociedad Española de Medicina Nuclear e Imagen Molecular

Lead sponsor

Source ClinicalTrials.gov
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