The Impact of Radiotherapy on Oligometastatic Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест To 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.
• Диагностический тест To 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.
• Диагностический тест To propose a diagnostic test for Oligometastatic Cancer (OC).
  Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.

Первичные конечные точки

• Radiological rate [Срок оценки: 3 months after treatment]
• Progression-Free Survival [Срок оценки: 5 years after treatment]
• SABR toxicities [Срок оценки: 5 years after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 21 центр

• Complejo Hospitalario Universitario Albacete — Albacete
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Institut Català d'Oncologia — Barcelona
• Hospital Universitario Virgen de las Nieves — Granada
• Hospital Universitari Arnau de Vilanova — Lleida
• Hospital de La Luz — Madrid
• Hospital Ruber Internacional — Madrid
• … и ещё 13 центров

Идентификаторы

NCT: NCT05933876 · OC-SABR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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