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NCT Number: NCT05933876

The Impact of Radiotherapy on Oligometastatic Cancer

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.

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Key information

About this study

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:

  • To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).

Diagnostic Test

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.

Diagnostic Test

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).

Diagnostic Test

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

Primary outcomes

  1. Radiological rate

    Time frame: 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.

  2. Progression-Free Survival

    Time frame: 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.

  3. SABR toxicities

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Joven, Prof.

CONTACT

[email protected]

+34977310300 ext. 55409

Meritxell Arenas, PhD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2037
Study completion
2037
First posted
Jul 6, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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