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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.

To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (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.

To propose a diagnostic test to determine the effectiveness of SABR.

Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.

To propose a diagnostic test for Oligometastatic Cancer (OC).

Jorge Joven, Prof.

Meritxell Arenas, PhD.

Jordi Camps, PhD.

Andrea Jiménez-Franco, MSc.

Helena Castañé, MSc.

Cristian Martínez-Navidad, BSc.

Cristina Placed-Gallego, BSc.

Yolanda López, M.D.

David Gómez, M.D.

Jordi Trilla, M.D.

Mònica Arguís, M.D.

Mauricio Murcia, M.D.

Fredy Castaño, M.D.

Miguel Árquez, M.D.

Rocío Benavides, M.D.

Cecilia Escuín, M.D.

Olga Engel, M.D.

Johana Acosta, M.D.

Bárbara Malave, M.D.

David Calderón, M.D.

Víctor Hernández, PhD.

Sebastià Sabater

Jady Vivian Rojas

Ismael Membrive

Victoria Reyes

Evelyn Martínez

Carlos Ferrer

Arancha Eraso

Rosario Del Moral

Moisés Mira

Sofía Sanchez

Aurora Rodríguez

Ángel Montero

Elia Del Cerro

Eva Fernández

Stephanyie Payano

Carlos Míguez

Josep Maria Solé

Ester Jordà

Amparo González

Reyes Ibáñez

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.

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:

1. To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and
2. 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.

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

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.

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.

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.

To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.

Spots Global Cancer Trial Database for to propose a diagnostic test to determine the effectiveness of sabr.