About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).
Trial design
Case-control
Other
Treatments tested in this trial
To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).
Diagnostic testAnalyze 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 testCollect 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 testAnalyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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Institut Investigacio Sanitaria Pere Virgili
Lead sponsor
Hospital Ruber Internacional
Collaborator
Hospital Universitario Rey Juan Carlos
Collaborator
Quirón Madrid University Hospital
Collaborator
Hospital de La Luz
Collaborator
Institut Català d'Oncologia
Collaborator
Hospital Arnau de Vilanova
Collaborator
Hospital Universitari Sant Joan de Reus
Collaborator
Hospital Universitario Virgen Macarena
Collaborator
Hospital Universitario Reina Sofia de Cordoba
Collaborator
Hospital General Universitario de Valencia
Collaborator
Hospital Clínico Universitario de Valencia
Collaborator
Complejo Hospitalario Universitario de Albacete
Collaborator
Hospital de Terrassa
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
Hospital del Mar
Collaborator
Hospital Provincial de Castellon
Collaborator
Hospital de la Santa creu i Sant Pau - Barcelona
Collaborator
HM Sanchinarro University Hospital
Collaborator
Hospital Miguel Servet
Collaborator
University Hospital Virgen de las Nieves
Collaborator
Hospital Vall d'Hebron
Collaborator