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

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ClinicalTrials.gov Identifier: NCT04949282
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
Sociedad Española de Medicina Nuclear e Imagen Molecular

Tracking Information
First Submitted Date June 14, 2021
First Posted Date July 2, 2021
Last Update Posted Date December 23, 2022
Actual Study Start Date May 10, 2021
Estimated Primary Completion Date December 31, 2034   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2021)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2021)
  • 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.
  • Adverse Events (AEs) [ Time Frame: Up to 12 months ]
    Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
  • Prognostic factors [ Time Frame: Up to 12 months ]
    Correlation of possible prognostic factors with clinical effectiveness outcomes.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spanish Series of Patients Treated With the Radionuclide Lutetium177
Official Title SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
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.
Detailed Description Patient data will be collected from medical records after obtaining consent and retrospectively.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
Condition
  • 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
Intervention
  • Drug: Lutetium [177Lu] oxodotreotide/dotatate
    Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
    Other Name: Lutathera
  • Device: Lutetium [177Lu] oxodotreotide/dotatate
    Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
    Other Name: Lutathera
Study Groups/Cohorts Lutathera
Interventions:
  • Drug: Lutetium [177Lu] oxodotreotide/dotatate
  • Device: Lutetium [177Lu] oxodotreotide/dotatate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 1, 2021)		 5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2035
Estimated Primary Completion Date December 31, 2034   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mercedes Dr Mitjavila Casanovas, MD-PhD 911916000 ext 46261 mercedes.mitjavila@salud.madrid.org
Contact: Paula Dr Jiménez Fonseca, MD-PhD 985106121 ext 36582 palucaji@hotmail.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04949282
Other Study ID Numbers SEM-LUT-2020-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Sociedad Española de Medicina Nuclear e Imagen Molecular
Original Responsible Party Same as current
Current Study Sponsor Sociedad Española de Medicina Nuclear e Imagen Molecular
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Mercedes Dr Mitjavila Casanovas, MD-PhD Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
PRS Account Sociedad Española de Medicina Nuclear e Imagen Molecular
Verification Date December 2022