The Impact of Radiotherapy on Oligometastatic Cancer

NCT ID: NCT05933876

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2037-12-31

Brief Summary

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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

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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.

Conditions

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Metastasis Metastatic Breast Cancer Metastatic Prostate Cancer Metastatic Colorectal Cancer Metastatic Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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OC-SABR

Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol.

To propose a diagnostic test to determine the viability of Stereotactic ABlative Radiotherapy (SABR).

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.

Controls

Individuals who have never been diagnosed with cancer or oligometastasis.

To propose a diagnostic test for Oligometastatic Cancer (OC).

Intervention Type DIAGNOSTIC_TEST

Analyze circulating tumoral DNA and metabolites from blood samples in search of the profile of OC.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ruber Internacional

OTHER

Sponsor Role collaborator

Hospital Universitario Rey Juan Carlos

OTHER

Sponsor Role collaborator

Quirón Madrid University Hospital

OTHER

Sponsor Role collaborator

Hospital de La Luz

OTHER

Sponsor Role collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role collaborator

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role collaborator

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role collaborator

Hospital General Universitario de Valencia

OTHER

Sponsor Role collaborator

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Albacete

OTHER

Sponsor Role collaborator

Hospital de Terrassa

OTHER

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Provincial de Castellon

OTHER

Sponsor Role collaborator

Hospital de la Santa creu i Sant Pau - Barcelona

OTHER

Sponsor Role collaborator

HM Sanchinarro University Hospital

OTHER

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role collaborator

University Hospital Virgen de las Nieves

OTHER

Sponsor Role collaborator

Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meritxell Arenas, PhD.

Role: STUDY_DIRECTOR

Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus

Locations

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Complejo Hospitalario Universitario Albacete

Albacete, Albacete, Spain

Site Status NOT_YET_RECRUITING

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

Barcelona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Institut Català d'Oncologia

Barcelona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Lleida, Spain

Site Status NOT_YET_RECRUITING

Hospital de La Luz

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Ruber Internacional

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Quirónsalud

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Rey Juan Carlos

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status NOT_YET_RECRUITING

Hospital General Univesitario de Valencia

Valencia, Valencia, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status NOT_YET_RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Provincial de Castellón

Castellon, , Spain

Site Status NOT_YET_RECRUITING

Institut Català d'Oncologia

Girona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital de Terrassa

Terrassa, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Jorge Joven, Prof.

Role: CONTACT

+34977310300 ext. 55409

Meritxell Arenas, PhD.

Role: CONTACT

Facility Contacts

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Sebastià Sabater

Role: primary

Jady Vivian Rojas

Role: primary

Victoria Reyes

Role: primary

Evelyn Martínez

Role: primary

Rosario Del Moral

Role: primary

Moisés Mira

Role: primary

Sofía Sanchez

Role: primary

Aurora Rodríguez

Role: primary

Ángel Montero

Role: primary

Elia Del Cerro

Role: primary

Stephanyie Payano

Role: primary

Carlos Míguez

Role: primary

Jorge Joven, Prof.

Role: primary

+977310300 ext. 55409

Meritxell Arenas, PhD.

Role: backup

Jordi Camps, PhD.

Role: backup

Andrea Jiménez-Franco, MSc.

Role: backup

Helena Castañé, MSc.

Role: backup

Cristian Martínez-Navidad, BSc.

Role: backup

Cristina Placed-Gallego, BSc.

Role: backup

Yolanda López, M.D.

Role: backup

David Gómez, M.D.

Role: backup

Jordi Trilla, M.D.

Role: backup

Mònica Arguís, M.D.

Role: backup

Mauricio Murcia, M.D.

Role: backup

Fredy Castaño, M.D.

Role: backup

Miguel Árquez, M.D.

Role: backup

Rocío Benavides, M.D.

Role: backup

Cecilia Escuín, M.D.

Role: backup

Olga Engel, M.D.

Role: backup

Johana Acosta, M.D.

Role: backup

Bárbara Malave, M.D.

Role: backup

David Calderón, M.D.

Role: backup

Víctor Hernández, PhD.

Role: backup

Ester Jordà

Role: primary

Amparo González

Role: primary

Reyes Ibáñez

Role: primary

Ismael Membrive

Role: primary

Carlos Ferrer

Role: primary

Arancha Eraso

Role: primary

Eva Fernández

Role: primary

Josep Maria Solé

Role: primary

Other Identifiers

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OC-SABR

Identifier Type: -

Identifier Source: org_study_id

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