SEPTRALU: Spanish Series of Patients Treated With the Radionuclide Lutetium177

Sponsor

Sociedad Española de Medicina Nuclear e Imagen Molecular (Other)

Overall Status

Recruiting

CT.gov ID

NCT04949282

Collaborator

(none)

5,000

Enrollment

Locations

175.7

Anticipated Duration (Months)

263.2

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

Actual Study Start Date :

May 10, 2021

Anticipated Primary Completion Date :

Dec 31, 2034

Anticipated Study Completion Date :

Dec 31, 2035

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) [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.
Overall survival (OS) [Up to 12 months]
Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Overall response rate (ORR) [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

Secondary Outcome Measures

Characteristics of the population . [Up to 12 months]
Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.
Adverse Events (AEs) [Up to 12 months]
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
Prognostic factors [Up to 12 months]
Correlation of possible prognostic factors with clinical effectiveness outcomes.
Areas for improvement care [Up to 12 months]
Identification of areas for improvement in the management and selection of patients for treatment with lutathera
Health-related Quality of Life (HRQoL) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico Universitario de Santiago	Santiago De Compostela	A Coruña	Spain	15706
2	Hospital Universitario Virgen de las Nieves	Granada	Andalucia	Spain	18014
3	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
4	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
5	Hospital Unviersitari Son Espases	Palma De Mallorca	Islas Baleares	Spain	07120
6	Hospital Universitario de Getafe	Getafe	Madrid	Spain	28905
7	Hospital Univeritario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
8	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
9	Clínica Universidad de Navarra	Pamplona	Navarra	Spain	31008
10	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
11	Hospital Universitario de Burgos	Burgos		Spain	09006
12	Hospital General Universitario de Ciudad Real	Ciudad Real		Spain	13005
13	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
14	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
15	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
16	Hospital Universitario La Paz	Madrid		Spain	28046
17	Hospital Universitario HM Sanchinarro	Madrid		Spain	28050
18	Hospital Universitario Doctor Peset	Valencia		Spain	46017
19	Hospital Universitario La Fe	Valencia		Spain	46026