Neuroendocrine TumorsSEPTRALUNCT04949282
Spanish Series of Patients Treated With the Radionuclide Lutetium177
An observational study of Neuroendocrine Tumors and Intestinal Neoplasms, run by Sociedad Española de Medicina Nuclear e Imagen Molecular at 20 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms
- What is being tested?
- Lutetium [177Lu] oxodotreotide/dotatate
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 5,000 participants
- Where
- 20 sitesSpain
- Study dates
- 10 May 2021to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mercedes Dr Mitjavila Casanovas, MD-PhD contact
20 sites in 1 country
Spain20 sites, 20 recruiting
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitario La Paz
Madrid, 28046
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 42621, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Not yet recruiting
Hospital Univeritario Puerta de Hierro
Majadahonda, Madrid, 28222
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Unviersitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario Doctor Peset
Valencia, 46017
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
- Recruiting
Hospital Universitario La Fe
Valencia, 46026
Mercedes Dr Mitjavila Casanovas, MD-PhD, 911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org
About this study
Official title: 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.
Read the detailed description
Patient data will be collected from medical records after obtaining consent and retrospectively.
- Conditions
- Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal
- Being tested
- Lutetium [177Lu] oxodotreotide/dotatate
- Keywords
- GEP-NET, Gastro-Entero-Pancreatic Neuroendocrine Tumour, Luthatera, Somatostatin receptor positive tumour
- Medical subject headings
- Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms by Histologic Type, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium [177Lu] oxodotreotide/dotatateDrug
Also called Lutathera
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Lutetium [177Lu] oxodotreotide/dotatateDevice
Also called Lutathera
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
| Study group | Role | What they receive |
|---|---|---|
| Lutathera | Not described Receives: Drug: Lutetium [177Lu] oxodotreotide/dotatate; Device: Lutetium [177Lu] oxodotreotide/dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Up to 12 months
Secondary outcomes (5)
Characteristics of the population .
Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.
Measured: Up to 12 months
Adverse Events (AEs)
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
Measured: Up to 12 months
Prognostic factors
Correlation of possible prognostic factors with clinical effectiveness outcomes.
Measured: Up to 12 months
Areas for improvement care
Identification of areas for improvement in the management and selection of patients for treatment with lutathera
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start10 May 2021
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Medicina Nuclear e Imagen Molecular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mercedes Dr Mitjavila Casanovas, MD-PhD, Principal investigator, Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949282
- Sponsor's protocol ID
- SEM-LUT-2020-01
- Acronym
- SEPTRALU
- Status last verified
- Dec 2022
- First submitted
- 14 Jun 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Mitjavila M, Jimenez-Fonseca P, Bello P, Pubul V, Percovich JC, Garcia-Burillo A, Hernando J, Arbizu J, Rodeno E, Estorch M, Llana B, Castellon M, Garcia-Canamaque L, Gajate P, Riesco MC, Miguel MB, Balaguer-Munoz D, Custodio A, Cano JM, Repetto A, Garcia-Alonso P, Muros MA, Vercher-Conejero JL, Carmona-Bayonas A. Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(8):2486-2500. doi: 10.1007/s00259-023-06166-8. Epub 2023 Mar 6.
PubMed 36877234
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
- ClinicalTrials.gov ID
- NCT04949282
- Acronym / sponsor ID
- SEPTRALU / SEM-LUT-2020-01
- Conditions
- Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal
- Keywords
- GEP-NET, Gastro-Entero-Pancreatic Neuroendocrine Tumour, Luthatera, Somatostatin receptor positive tumour
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sociedad Española de Medicina Nuclear e Imagen MolecularUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutathera | – | Drug: Lutetium [177Lu] oxodotreotide/dotatate, Device: Lutetium [177Lu] oxodotreotide/dotatate |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetium [177Lu] oxodotreotide/dotatateAlso: LutatheraRadiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) | Drug | Lutathera |
| Lutetium [177Lu] oxodotreotide/dotatateAlso: LutatheraRadiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) | Device | Lutathera |
Primary outcome
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
5 secondary outcomes
Characteristics of the population .
Time frame: Up to 12 months
Adverse Events (AEs)
Time frame: Up to 12 months
Prognostic factors
Time frame: Up to 12 months
Areas for improvement care
Time frame: Up to 12 months
Health-related Quality of Life (HRQoL)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Derived from this study: PubMed 36877234Mitjavila M, Jimenez-Fonseca P, Bello P, Pubul V, Percovich JC, Garcia-Burillo A, Hernando J, Arbizu J, Rodeno E, Estorch M, Llana B, Castellon M, Garcia-Canamaque L, Gajate P, Riesco MC, Miguel MB, Balaguer-Munoz D, Custodio A, Cano JM, Repetto A, Garcia-Alonso P, Muros MA, Vercher-Conejero JL, Carmona-Bayonas A. Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(8):2486-2500. doi: 10.1007/s00259-023-06166-8. Epub 2023 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mercedes Dr Mitjavila Casanovas, MD-PhD contact
Mercedes Dr Mitjavila Casanovas, MD-PhD principal investigator
Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Intestinal Neoplasms, run by Sociedad Española de Medicina Nuclear e Imagen Molecular at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mercedes Dr Mitjavila Casanovas, MD-PhD (911916000 ext. 46261, mercedes.mitjavila@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.