The Impact of Radiotherapy on Oligometastatic Cancer

November 14, 2024 updated by: Institut Investigacio Sanitaria Pere Virgili

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain
        • Not yet recruiting
        • Complejo Hospitalario Universitario Albacete
        • Contact:
          • Sebastià Sabater
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital del Mar
        • Contact:
          • Ismael Membrive
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Victoria Reyes
      • Barcelona, Spain
        • Not yet recruiting
        • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
        • Contact:
          • Jady Vivian Rojas
      • Barcelona, Spain
        • Not yet recruiting
        • Institut Catala d'Oncologia
        • Contact:
          • Evelyn Martínez
      • Castelló de la Plana, Spain
        • Not yet recruiting
        • Hospital Provincial de Castellon
        • Contact:
          • Carlos Ferrer
      • Girona, Spain
        • Not yet recruiting
        • Institut Catala d'Oncologia
        • Contact:
          • Arancha Eraso
      • Granada, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Rosario Del Moral
      • Lleida, Spain
        • Not yet recruiting
        • Hospital Universitari Arnau de Vilanova
        • Contact:
          • Moisés Mira
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Rey Juan Carlos
        • Contact:
          • Stephanyie Payano
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Eva Fernández
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Ruber Internacional
        • Contact:
          • Aurora Rodríguez
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
          • Ángel Montero
      • Madrid, Spain
        • Not yet recruiting
        • Hospital de la Luz
        • Contact:
          • Sofía Sanchez
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Quirónsalud
        • Contact:
          • Elia Del Cerro
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Carlos Míguez
      • Terrassa, Spain
        • Not yet recruiting
        • Hospital de Terrassa
        • Contact:
          • Josep Maria Solé
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Ester Jordà
      • Valencia, Spain
        • Not yet recruiting
        • Hospital General Univesitario de Valencia
        • Contact:
          • Amparo González
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitari Miguel Servet
        • Contact:
          • Reyes Ibáñez
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Recruiting
        • Hospital Universitari Sant Joan de Reus
        • Contact:
        • Contact:
        • Contact:
          • Jordi Camps, PhD.
        • Contact:
          • Andrea Jiménez-Franco, MSc.
        • Contact:
          • Helena Castañé, MSc.
        • Contact:
          • Cristian Martínez-Navidad, BSc.
        • Contact:
          • Cristina Placed-Gallego, BSc.
        • Contact:
          • Yolanda López, M.D.
        • Contact:
          • David Gómez, M.D.
        • Contact:
          • Jordi Trilla, M.D.
        • Contact:
          • Mònica Arguís, M.D.
        • Contact:
          • Mauricio Murcia, M.D.
        • Contact:
          • Fredy Castaño, M.D.
        • Contact:
          • Miguel Árquez, M.D.
        • Contact:
          • Rocío Benavides, M.D.
        • Contact:
          • Cecilia Escuín, M.D.
        • Contact:
          • Olga Engel, M.D.
        • Contact:
          • Johana Acosta, M.D.
        • Contact:
          • Bárbara Malave, M.D.
        • Contact:
          • David Calderón, M.D.
        • Contact:
          • Víctor Hernández, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients attending the collaboration hospitals to receive Stereotactic ABlative Radiotherapy (SABR) to treat Oligometastatic Cancer (OC).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OC-SABR
Patients diagnosed with Oligometastatic Cancer (OC) that will receive Stereotactic ABlative Radiotherapy (SABR) that has been prescribed per clinical protocol.
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.
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.
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.
Controls
Individuals who have never been diagnosed with cancer or oligometastasis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological rate
Time Frame: 3 months after treatment

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
Progression-Free Survival
Time Frame: 5 years after treatment
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
SABR toxicities
Time Frame: 5 years after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Collaborators

Institut Català d'Oncologia
Hospital Universitario Ramon y Cajal
Hospital Arnau de Vilanova
Hospital del Mar
Hospital Universitario Virgen Macarena
Complejo Hospitalario Universitario de Albacete
Hospital Universitario Reina Sofia de Cordoba
Hospital Vall d'Hebron
Hospital Provincial de Castellon
Hospital Miguel Servet
Hospital de Terrassa
Hospital Universitari Sant Joan de Reus
Hospital General Universitario de Valencia
Quirón Madrid University Hospital
Hospital Ruber Internacional
University Hospital Virgen de las Nieves
Hospital Clínico Universitario de Valencia
Hospital de La Luz
Hospital Universitario Rey Juan Carlos
Hospital de la Santa creu i Sant Pau - Barcelona
HM Sanchinarro University Hospital

Investigators

  • Study Director: Meritxell Arenas, PhD., Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

December 31, 2037

Study Completion (Estimated)

December 31, 2037

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC-SABR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2024 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity.

Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R).

The external collaborators, especially those involved in validation cohorts, may have access to data upon request.

With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.

IPD Sharing Time Frame

Once decided the repository web address.

IPD Sharing Access Criteria

Decided by the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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