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Spots Global Cancer Trial Database for The Impact of Radiotherapy on Oligometastatic Cancer

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Trial Identification

Brief Title: The Impact of Radiotherapy on Oligometastatic Cancer

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

Study ID: NCT05933876

Study Description

Brief 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). 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain

Complejo Hospitalario Universitario Albacete, Albacete, , Spain

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital Universitari Vall d'Hebron, Barcelona, , Spain

Institut Català d'Oncologia, Barcelona, , Spain

Hospital Provincial de Castellón, Castelló de la Plana, , Spain

Institut Català d'Oncologia, Girona, , Spain

Hospital Universitario Virgen de las Nieves, Granada, , Spain

Hospital Universitari Arnau de Vilanova, Lleida, , Spain

Hospital de La Luz, Madrid, , Spain

Hospital Ruber Internacional, Madrid, , Spain

Hospital Universitario HM Sanchinarro, Madrid, , Spain

Hospital Universitario Quirónsalud, Madrid, , Spain

Hospital Universitario Ramón y Cajal, Madrid, , Spain

Hospital Universitario Rey Juan Carlos, Madrid, , Spain

Hospital Universitario Virgen Macarena, Sevilla, , Spain

Hospital de Terrassa, Terrassa, , Spain

Hospital Clínico Universitario de Valencia, Valencia, , Spain

Hospital General Univesitario de Valencia, Valencia, , Spain

Hospital Universitari Miguel Servet, Zaragoza, , Spain

Contact Details

Name: Meritxell Arenas, PhD.

Affiliation: Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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