The Impact of Radiotherapy on Oligometastatic Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).: 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 effectiveness of 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 for Oligometastatic Cancer (OC).: Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.

Study 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.

Eligibility

Primary outcome measure(s)

• Radiological rate — 3 months after treatment
  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 — 5 years after treatment
  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 — 5 years after treatment
  To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.

Trial sites (21)

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