Clinical trial NCT05933876: The Impact of Radiotherapy on Oligometastatic Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastasis
Metastatic Breast Cancer
Metastatic Prostate Cancer
Metastatic Colorectal Cancer
Metastatic Lung Cancer
Keywords: Metastasis
Radiosurgery
Metabolomics
Radiomics
Multi-omics
Molecular subtypes
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
Collaborators: name: Hospital Ruber Internacional
name: Hospital Universitario Rey Juan Carlos
name: Quirón Madrid University Hospital
name: Hospital de La Luz
name: Institut Català d'Oncologia
name: Hospital Arnau de Vilanova
name: Hospital Universitari Sant Joan de Reus
name: Hospital Universitario Virgen Macarena
name: Hospital Universitario Reina Sofia de Cordoba
name: Hospital General Universitario de Valencia
name: Hospital Clínico Universitario de Valencia
name: Complejo Hospitalario Universitario de Albacete
name: Hospital de Terrassa
name: Hospital Universitario Ramon y Cajal
name: Hospital del Mar
name: Hospital Provincial de Castellon
name: Hospital de la Santa creu i Sant Pau - Barcelona
name: HM Sanchinarro University Hospital
name: Hospital Miguel Servet
name: University Hospital Virgen de las Nieves
name: Hospital Vall d'Hebron
First posted: 2023-07-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).

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.

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.

Primary outcomes:
measure: Radiological rate
timeFrame: 3 months after treatment
measure: Progression-Free Survival
timeFrame: 5 years after treatment
measure: SABR toxicities
timeFrame: 5 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario Albacete
city: Barcelona
country: Spain
facility: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia
city: Castelló de la Plana
country: Spain
facility: Hospital Provincial de Castellón
city: Girona
country: Spain
facility: Institut Català d'Oncologia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital de La Luz
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Terrassa
country: Spain
facility: Hospital de Terrassa
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Univesitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitari Miguel Servet
Study officials:
affiliation: Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
name: Meritxell Arenas, PhD.
role: STUDY_DIRECTOR
References: