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
Trial ID: NCT05933876
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2022-12-01
Completion date: 2037-12-31
Sponsor: Institut Investigacio Sanitaria Pere Virgili
Collaborators: Hospital Ruber Internacional; Hospital Universitario Rey Juan Carlos; Quirón Madrid University Hospital; Hospital de La Luz; Institut Català d'Oncologia; Hospital Arnau de Vilanova; Hospital Universitari Sant Joan de Reus; Hospital Universitario Virgen Macarena; Hospital Universitario Reina Sofia de Cordoba; Hospital General Universitario de Valencia; Hospital Clínico Universitario de Valencia; Complejo Hospitalario Universitario de Albacete; Hospital de Terrassa; Hospital Universitario Ramon y Cajal; Hospital del Mar; Hospital Provincial de Castellon; Hospital de la Santa creu i Sant Pau - Barcelona; HM Sanchinarro University Hospital; Hospital Miguel Servet; University Hospital Virgen de las Nieves; Hospital Vall d'Hebron
Conditions: Metastasis; Metastatic Breast Cancer; Metastatic Prostate Cancer; Metastatic Colorectal Cancer; Metastatic Lung Cancer
Interventions: To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).; To propose a diagnostic test to determine the effectiveness of SABR.; To propose a diagnostic test for Oligometastatic Cancer (OC).
Locations: Complejo Hospitalario Universitario Albacete; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hospital Universitari Vall d'Hebron; Institut Català d'Oncologia; Hospital Universitario Virgen de las Nieves; Hospital Universitari Arnau de Vilanova; Hospital de La Luz; Hospital Ruber Internacional; Hospital Universitario HM Sanchinarro; Hospital Universitario Quirónsalud; Hospital Universitario Rey Juan Carlos; Hospital Universitario Virgen Macarena; Hospital Universitari Sant Joan de Reus; Hospital Clínico Universitario de Valencia; Hospital General Univesitario de Valencia; Hospital Universitari Miguel Servet; Hospital del Mar; Hospital Provincial de Castellón; Institut Català d'Oncologia; Hospital Universitario Ramón y Cajal; Hospital de Terrassa
Countries: Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain; Spain
Enrollment: 2000
Age range: 18 Years - None
Sex: ALL

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 criteria:
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.

Outcomes:
Radiological rate; Progression-Free Survival; SABR toxicities