RecruitingNCT05933876

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


Sponsor

Institut Investigacio Sanitaria Pere Virgili

Enrollment

2,000 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.
  • 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 Criteria4

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

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.


Locations(21)

Complejo Hospitalario Universitario Albacete

Albacete, Albacete, Spain

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

Barcelona, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Institut Català d'Oncologia

Barcelona, Barcelona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Lleida, Spain

Hospital de La Luz

Madrid, Madrid, Spain

Hospital Ruber Internacional

Madrid, Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

Hospital Universitario Quirónsalud

Madrid, Madrid, Spain

Hospital Universitario Rey Juan Carlos

Madrid, Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Hospital General Univesitario de Valencia

Valencia, Valencia, Spain

Hospital Universitari Miguel Servet

Zaragoza, Zaragoza, Spain

Hospital del Mar

Barcelona, Spain

Hospital Provincial de Castellón

Castellon, Spain

Institut Català d'Oncologia

Girona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital de Terrassa

Terrassa, Spain

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NCT05933876


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