MetastasisNCT05933876
The Impact of Radiotherapy on Oligometastatic Cancer
An observational study of Metastasis and Metastatic Breast Cancer, run by Institut Investigacio Sanitaria Pere Virgili at 21 sites in Spain.
Trial summary
Metastases represent the most threatening challenge in cancer. One of the management strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative Radiotherapy (SABR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis, Metastatic Breast Cancer, Metastatic Prostate Cancer
- What is being tested?
- To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR)., To propose a diagnostic test to determine the effectiveness of SABR. and To propose a diagnostic test for Oligometastatic Cancer (OC).
- How many people
- 2,000 participants
- Where
- 21 sitesSpain
- Study dates
- 1 Dec 2022to 31 Dec 2037
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
Who may be able to join
- Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.
- 18 years old or older.
- Up to five metastases located in the bone, lung, node, liver or brain.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 0 or 1.
Who cannot join
- Non-melanoma skin cancer.
- Previous radiotherapy in the same anatomic location.
- Presence of vascular collagen disease.
- Pregnancy or lactation at the time of inclusion.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Meritxell Arenas, PhD. contact
21 sites in 1 country
Spain21 sites, 21 recruiting
- Not yet recruiting
Complejo Hospitalario Universitario Albacete
Albacete, Albacete
Sebastià Sabater
- Not yet recruiting
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Jady Vivian Rojas
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona
Victoria Reyes
- Not yet recruiting
Institut Català d'Oncologia
Barcelona, Barcelona
Evelyn Martínez
- Not yet recruiting
Hospital del Mar
Barcelona
Ismael Membrive
- Not yet recruiting
Hospital Provincial de Castellón
Castellon
Carlos Ferrer
- Not yet recruiting
Institut Català d'Oncologia
Girona
Arancha Eraso
- Not yet recruiting
Hospital Universitario Virgen de las Nieves
Granada, Granada
Rosario Del Moral
- Not yet recruiting
Hospital Universitari Arnau de Vilanova
Lleida, Lleida
Moisés Mira
- Not yet recruiting
Hospital de La Luz
Madrid, Madrid
Sofía Sanchez
- Not yet recruiting
Hospital Ruber Internacional
Madrid, Madrid
Aurora Rodríguez
- Not yet recruiting
Hospital Universitario HM Sanchinarro
Madrid, Madrid
Ángel Montero
- Not yet recruiting
Hospital Universitario Quirónsalud
Madrid, Madrid
Elia Del Cerro
- Not yet recruiting
Hospital Universitario Rey Juan Carlos
Madrid, Madrid
Stephanyie Payano
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid
Eva Fernández
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204
Jorge Joven, Prof., +977310300 ext. 55409, jorge.joven@urv.cat
Meritxell Arenas, PhD., meritxell.arenas@urv.cat
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla
Carlos Míguez
- Not yet recruiting
Hospital de Terrassa
Terrassa
Josep Maria Solé
- Not yet recruiting
Hospital Clínico Universitario de Valencia
Valencia, Valencia
Ester Jordà
- Not yet recruiting
Hospital General Univesitario de Valencia
Valencia, Valencia
Amparo González
- Not yet recruiting
Hospital Universitari Miguel Servet
Zaragoza, Zaragoza
Reyes Ibáñez
About this study
Official title: Stereotactic ABlative Radiotherapy (SABR) in Oligometastatic Cancer (OC): a Radiomics, Multi-omics, and Machine Learning Approach to Clinical Decision-making. the OC-SABR Multicentric Project
Metastases represent the most threatening challenge in cancer. One of the management strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative Radiotherapy (SABR). However, there are few studies, and there is no defined clinical standard, nor are the radiobiological mechanisms that contribute to treatment response well understood. The focus should be on generating evidence to guide the personalization of radiotherapy beyond solely technological and anatomical precision. This could be achieved by recollecting clinical and biological data from patients that undergo this treatment and analyzing them to ultimately predict, with the help of artificial intelligence, which patients will be the most beneficiary and improve their survival rate.
Read the detailed description
Metastases are the most threatening challenge in cancer. In patients with metastatic cancer, local radiotherapy treatment remains an essential tool with different goals that depend on numerous factors, especially on the number and extent of the metastases and whether disease control is feasible and desirable according to the expected quality of life. Oligometastatic Cancer (OC), i.e., a few metastases in a few organs, has been recently incorporated as a less aggressive state than widely disseminated metastatic disease. Consequently, OC is a serious candidate for aggressive treatments based on Stereotactic ABlative Radiotherapy (SABR). This treatment has shown promising results and is already incorporated into habitual clinical practices. However, OC is a complex and heterogeneous disease, and not all patients have improved their life quality and expectation. Identifying patients who would benefit from this treatment is an important area of research that needs factual information from a large sample provided by multiple centers. Therefore, this multicenter, retrospective, prospective, observational, and longitudinal study incorporates clinical data, medical images, and biological samples to feed artificial intelligence algorithms. The objective is to determine which patient profile achieves complete response after SABR. The secondary objectives are:
- To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and
- To evaluate intratumoral metabolites released into circulation by multi-omics analyses.
These will contribute to determining the systemic molecular effects of treatment in search of biomarkers with predictive value.
Centralized storage of patient management data, clinical image analysis, and candidate biomarkers measured in blood samples may eventually meet the expectations of integrating data into clinical decision-making and influence evolution based on precision medicine.
- Conditions
- Metastasis, Metastatic Breast Cancer, Metastatic Prostate Cancer, Metastatic Colorectal Cancer, Metastatic Lung Cancer
- Being tested
- To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR)., To propose a diagnostic test to determine the effectiveness of SABR., To propose a diagnostic test for Oligometastatic Cancer (OC).
- Keywords
- Metastasis, Radiosurgery, Metabolomics, Radiomics, Multi-omics, Molecular subtypes
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).Diagnostic test
Analyze clinical data, medical images and molecular circulating features to propose which variables serve to select the patients that will achieve complete response after SABR.
To propose a diagnostic test to determine the effectiveness of SABR.Diagnostic test
Collect blood samples at five different time points before and after treatment and analyze circulating tumoral DNA, medical images, and metabolites to monitor the effect of SABR and its effectiveness.
To propose a diagnostic test for Oligometastatic Cancer (OC).Diagnostic test
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
| Study group | Role | What they receive |
|---|---|---|
| OC-SABR | Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol. Receives: Diagnostic Test: To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).; Diagnostic Test: To propose a diagnostic test to determine the effectiveness of SABR.; Diagnostic Test: To propose a diagnostic test for Oligometastatic Cancer (OC). | |
| Controls | Individuals who have never been diagnosed with cancer or oligometastasis. Receives: Diagnostic Test: To propose a diagnostic test for Oligometastatic Cancer (OC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological rate
Images obtained by computerized tomography, magnetic resonance and positron emission tomography serve to evaluate the local control and response rate by:
- Complete response: absence of disease.
- Stable disease: no changes.
- Partial response: 50% or more injury reduction.
- Progression: 25% or more tumor size increase.
According to RECIST Criteria 1.1 and PERCIST.
Measured: 3 months after treatment
Progression-Free Survival
To assess the impact of SABR on the progression over time, precisely at 1, 2, 3, and 5 years, regarding Progression-Free Survival (PFS) based on RECIST Criteria 1.1 and PERCIST.
Measured: 5 years after treatment
SABR toxicities
To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies 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-control
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Ruber Internacional, Hospital Universitario Rey Juan Carlos, Quirón Madrid University Hospital, Hospital de La Luz, Institut Català d'Oncologia, Hospital Arnau de Vilanova, Hospital Universitari Sant Joan de Reus, Hospital Universitario Virgen Macarena, Hospital Universitario Reina Sofia de Cordoba, Hospital General Universitario de Valencia, Hospital Clínico Universitario de Valencia, Complejo Hospitalario Universitario de Albacete, Hospital de Terrassa, Hospital Universitario Ramon y Cajal, Hospital del Mar, Hospital Provincial de Castellon, Hospital de la Santa creu i Sant Pau - Barcelona, HM Sanchinarro University Hospital, Hospital Miguel Servet, University Hospital Virgen de las Nieves, Hospital Vall d'Hebron
- Responsible party
- Sponsor
- Investigators
- Meritxell Arenas, PhD., Study director, Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933876
- Sponsor's protocol ID
- OC-SABR
- Status last verified
- Nov 2024
- First submitted
- 28 Mar 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2024 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity. Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R). The external collaborators, especially those involved in validation cohorts, may have access to data upon request. With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic ABlative Radiotherapy (SABR) in Oligometastatic Cancer (OC): a Radiomics, Multi-omics, and Machine Learning Approach to Clinical Decision-making. the OC-SABR Multicentric Project
- ClinicalTrials.gov ID
- NCT05933876
- Acronym / sponsor ID
- OC-SABR
- Conditions
- Metastasis, Metastatic Breast Cancer, Metastatic Prostate Cancer, Metastatic Colorectal Cancer, Metastatic Lung Cancer
- Keywords
- Metastasis, Radiosurgery, Metabolomics, Radiomics, Multi-omics, Molecular subtypes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Hospital Ruber Internacional, Hospital Universitario Rey Juan Carlos, Quirón Madrid University Hospital, Hospital de La Luz, Institut Català d'Oncologia, Hospital Arnau de Vilanova, Hospital Universitari Sant Joan de Reus, Hospital Universitario Virgen Macarena, Hospital Universitario Reina Sofia de Cordoba, Hospital General Universitario de Valencia, Hospital Clínico Universitario de Valencia, Complejo Hospitalario Universitario de Albacete, Hospital de Terrassa, Hospital Universitario Ramon y Cajal, Hospital del Mar, Hospital Provincial de Castellon, Hospital de la Santa creu i Sant Pau - Barcelona, HM Sanchinarro University Hospital, Hospital Miguel Servet, University Hospital Virgen de las Nieves, Hospital Vall d'Hebron
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 6 Jul 2023 (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.
Metastases represent the most threatening challenge in cancer. One of the management strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative Radiotherapy (SABR). However, there are few studies, and there is no defined clinical standard, nor are the radiobiological mechanisms that contribute to treatment response well understood. The focus should be on generating evidence to guide the personalization of radiotherapy beyond solely technological and anatomical precision. This could be achieved by recollecting clinical and biological data from patients that undergo this treatment and analyzing them to ultimately predict, with the help of artificial intelligence, which patients will be the most beneficiary and improve their survival rate.
Detailed description
Metastases are the most threatening challenge in cancer. In patients with metastatic cancer, local radiotherapy treatment remains an essential tool with different goals that depend on numerous factors, especially on the number and extent of the metastases and whether disease control is feasible and desirable according to the expected quality of life. Oligometastatic Cancer (OC), i.e., a few metastases in a few organs, has been recently incorporated as a less aggressive state than widely disseminated metastatic disease. Consequently, OC is a serious candidate for aggressive treatments based on Stereotactic ABlative Radiotherapy (SABR). This treatment has shown promising results and is already incorporated into habitual clinical practices. However, OC is a complex and heterogeneous disease, and not all patients have improved their life quality and expectation. Identifying patients who would benefit from this treatment is an important area of research that needs factual information from a large sample provided by multiple centers. Therefore, this multicenter, retrospective, prospective, observational, and longitudinal study incorporates clinical data, medical images, and biological samples to feed artificial intelligence algorithms. The objective is to determine which patient profile achieves complete response after SABR. The secondary objectives are:
- To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and
- To evaluate intratumoral metabolites released into circulation by multi-omics analyses.
These will contribute to determining the systemic molecular effects of treatment in search of biomarkers with predictive value.
Centralized storage of patient management data, clinical image analysis, and candidate biomarkers measured in blood samples may eventually meet the expectations of integrating data into clinical decision-making and influence evolution based on precision medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC-SABR | – | Diagnostic Test: To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR)., Diagnostic Test: To propose a diagnostic test to determine the effectiveness of SABR., Diagnostic Test: To propose a diagnostic test for Oligometastatic Cancer (OC).Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol. |
| Controls | – | Diagnostic Test: To propose a diagnostic test for Oligometastatic Cancer (OC).Individuals who have never been diagnosed with cancer or oligometastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
Key inclusion criteria (4 listed)
- Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.
- 18 years old or older.
- Up to five metastases located in the bone, lung, node, liver or brain.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 0 or 1.
Key exclusion criteria (4 listed)
- Non-melanoma skin cancer.
- Previous radiotherapy in the same anatomic location.
- Presence of vascular collagen disease.
- Pregnancy or lactation at the time of inclusion.
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 |
|---|---|---|
| To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).Analyze clinical data, medical images and molecular circulating features to propose which variables serve to select the patients that will achieve complete response after SABR. | Diagnostic test | OC-SABR |
| To propose a diagnostic test to determine the effectiveness of SABR.Collect blood samples at five different time points before and after treatment and analyze circulating tumoral DNA, medical images, and metabolites to monitor the effect of SABR and its effectiveness. | Diagnostic test | OC-SABR |
| To propose a diagnostic test for Oligometastatic Cancer (OC).Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC. | Diagnostic test | Controls, OC-SABR |
Primary outcome
Radiological rate
Time frame: 3 months after treatment
Images obtained by computerized tomography, magnetic resonance and positron emission tomography serve to evaluate the local control and response rate by: * Complete response: absence of disease. * Stable disease: no changes. * Partial response: 50% or more injury reduction. * Progression: 25% or more tumor size increase. According to RECIST Criteria 1.1 and PERCIST.
Progression-Free Survival
Time frame: 5 years after treatment
To assess the impact of SABR on the progression over time, precisely at 1, 2, 3, and 5 years, regarding Progression-Free Survival (PFS) based on RECIST Criteria 1.1 and PERCIST.
SABR toxicities
Time frame: 5 years after treatment
To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.
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 18 Nov 2024.
- Individual participant dataSharing planned: Yes. The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2024 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity. Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R). The external collaborators, especially those involved in validation cohorts, may have access to data upon request. With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.
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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.
Meritxell Arenas, PhD. contact
Meritxell Arenas, PhD. study director
Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis and Metastatic Breast Cancer, run by Institut Investigacio Sanitaria Pere Virgili at 21 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 4 inclusion and 4 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 Jorge Joven, Prof. (+34977310300 ext. 55409, jorge.joven@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological rate (time frame: 3 months after treatment). 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?
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 18 Nov 2024.