Spanish Series Of Patients Treated With The Radionuclide Lutetium177

Study Overview

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.

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

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

DRUG: Lutetium [177Lu] oxodotreotide/dotatate
DEVICE: Lutetium [177Lu] oxodotreotide/dotatate

SEM-LUT-2020-01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-06-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-12-22
First Submitted that Met QC Criteria 2021-07-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-12-23
First Posted (ACTUAL) 2021-07-02	Results First Posted N/A	Last Verified 2022-12

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Lutathera	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)

Participant Group/Arm

Intervention/Treatment

: Lutathera

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)

Primary Outcome Measures	Measure Description	Time Frame
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
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
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 Outcome Measures	Measure Description	Time Frame
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
Adverse Events (AEs)	Toxicity will be collected according to grades (NCT-CTCAE) and consequences.	Up to 12 months
Prognostic factors	Correlation of possible prognostic factors with clinical effectiveness outcomes.	Up to 12 months
Areas for improvement care	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)	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

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

Name: Mercedes Dr Mitjavila Casanovas, MD-PhD

Phone Number: 911916000

Email: mercedes.mitjavila@salud.madrid.org

Study Contact Backup

Name: Paula Dr Jiménez Fonseca, MD-PhD

Phone Number: 985106121

Email: palucaji@hotmail.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

None

Collaborators and Investigators

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

Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record