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.
Study Type
OBSERVATIONAL
Enrollment
2,000
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.
Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Complejo Hospitalario Universitario Albacete
Albacete, Albacete, Spain
NOT_YET_RECRUITINGFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGInstitut Català d'Oncologia
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario Virgen de las Nieves
Granada, Granada, Spain
NOT_YET_RECRUITINGHospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
NOT_YET_RECRUITINGHospital de La Luz
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital Ruber Internacional
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Quirónsalud
Madrid, Madrid, Spain
NOT_YET_RECRUITING...and 11 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years after treatment
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