The Impact of Radiotherapy on Oligometastatic Cancer

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933876
• Other study ID #: OC-SABR
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2037

Study information

• Verified date: July 2023
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: Jorge Joven, Prof.
• Phone: +34977310300
• Email: jorge.joven[@]urv.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2037
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastasis
• Metastatic Breast Cancer
• Metastatic Colorectal Cancer
• Metastatic Lung Cancer
• Metastatic Prostate Cancer
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Albacete	Albacete
Spain	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia	Barcelona
Spain	Hospital Provincial de Castellón	Castelló de la Plana
Spain	Institut Català d'Oncologia	Girona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital de La Luz	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario Quirónsalud	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Madrid
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital de Terrassa	Terrassa
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital General Univesitario de Valencia	Valencia
Spain	Hospital Universitari Miguel Servet	Zaragoza

Sponsors (22)

Lead Sponsor

Collaborator

Institut Investigacio Sanitaria Pere Virgili

Complejo Hospitalario Universitario de Albacete, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, HM Sanchinarro University Hospital, Hospital Arnau de Vilanova, Hospital Clínico Universitario de Valencia, Hospital de La Luz, Hospital de Terrassa, Hospital del Mar, 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, Institut Català d'Oncologia, Quirón Madrid University Hospital, University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological rate	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.	3 months after treatment
Primary	Progression-Free Survival	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.	5 years after treatment
Primary	SABR toxicities	To evaluate the progression of SABR toxicities over time, precisely at 1, 2, 3, and 5 years, according to the CTCAE 4.0 scale.	5 years after treatment