The Impact of Radiotherapy on Oligometastatic Cancer
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
Sponsor study identifier
observational
2,000
1 country
21
Study Start
December 1, 2022
Actual (reported)Primary Completion
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2022
Actual (reported)March 28, 2023
Actual (reported)July 6, 2023
Actual (reported)December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol.
Individuals who have never been diagnosed with cancer or oligometastasis.
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.
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.
Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
Complejo Hospitalario Universitario Albacete
Albacete, Albacete, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Plasma, serum, and DNA samples.
Meritxell Arenas, PhD.
Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
First Submitted
March 28, 2023
First Posted
July 6, 2023
Study Start
December 1, 2022
Actual (reported)Primary Completion
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
5 years after treatment
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Institut Català d'Oncologia
Barcelona, Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
Hospital de La Luz
Madrid, Madrid, Spain
Hospital Ruber Internacional
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
Hospital Universitario Quirónsalud
Madrid, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Madrid, Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital General Univesitario de Valencia
Valencia, Valencia, Spain
Hospital Universitari Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital del Mar
Barcelona, Spain
Hospital Provincial de Castellón
Castellon, Spain
Institut Català d'Oncologia
Girona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital de Terrassa
Terrassa, Spain
Study Completion
December 31, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 18, 2024
Record last verified: 2024-11
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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Source: ClinicalTrials.gov.
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