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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05933876
Enrollment
2000
Registered
2023-07-06
Start date
2022-12-01
Completion date
2037-12-31
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Lung Cancer, Metastatic Prostate Cancer

Keywords

Metastasis, Radiosurgery, Metabolomics, Radiomics, Multi-omics, Molecular subtypes

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.

Interventions

DIAGNOSTIC_TESTTo 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.

DIAGNOSTIC_TESTTo 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.

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

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

Sponsors

Hospital Ruber Internacional
CollaboratorOTHER
Hospital Universitario Rey Juan Carlos
CollaboratorOTHER
Quirón Madrid University Hospital
CollaboratorOTHER
Hospital de La Luz
CollaboratorOTHER
Institut Català d'Oncologia
CollaboratorOTHER
Hospital Arnau de Vilanova
CollaboratorOTHER
Hospital Universitari Sant Joan de Reus
CollaboratorOTHER
Hospital Universitario Virgen Macarena
CollaboratorOTHER
Hospital Universitario Reina Sofia de Cordoba
CollaboratorOTHER_GOV
Hospital General Universitario de Valencia
CollaboratorOTHER
Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Complejo Hospitalario Universitario de Albacete
CollaboratorOTHER
Hospital de Terrassa
CollaboratorOTHER
Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Hospital Provincial de Castellon
CollaboratorOTHER
Hospital de la Santa creu i Sant Pau - Barcelona
CollaboratorOTHER
HM Sanchinarro University Hospital
CollaboratorOTHER
Hospital Miguel Servet
CollaboratorOTHER
University Hospital Virgen de las Nieves
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
Institut Investigacio Sanitaria Pere Virgili
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Non-melanoma skin cancer. * Previous radiotherapy in the same anatomic location. * Presence of vascular collagen disease. * Pregnancy or lactation at the time of inclusion.

Design outcomes

Primary

MeasureTime frameDescription
Radiological rate3 months after treatmentImages 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 Survival5 years after treatmentTo 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 toxicities5 years after treatmentTo evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.

Countries

Spain

Contacts

Primary ContactJorge Joven, Prof.
jorge.joven@urv.cat+34977310300
Backup ContactMeritxell Arenas, PhD.
meritxell.arenas@urv.cat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026