NCT05933876

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
142mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Dec 2022Dec 2037

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

15.1 years

First QC Date

March 28, 2023

Last Update Submit

November 14, 2024

Conditions

MetastasisMetastatic Breast CancerMetastatic Prostate CancerMetastatic Colorectal CancerMetastatic Lung Cancer

Keywords

MetastasisRadiosurgeryMetabolomicsRadiomicsMulti-omicsMolecular subtypes

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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).Diagnostic Test: To propose a diagnostic test to determine the effectiveness of SABR.Diagnostic Test: To propose a diagnostic test for Oligometastatic Cancer (OC).

Controls

Individuals who have never been diagnosed with cancer or oligometastasis.

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

Interventions

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

OC-SABR
To propose a diagnostic test to determine the effectiveness of SABR.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.

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

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

ControlsOC-SABR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.
  • 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.

You may not qualify if:

  • Non-melanoma skin cancer.
  • Previous radiotherapy in the same anatomic location.
  • Presence of vascular collagen disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Complejo Hospitalario Universitario Albacete

Albacete, Albacete, Spain

NOT YET RECRUITING

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

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Institut Català d'Oncologia

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

NOT YET RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Lleida, Spain

NOT YET RECRUITING

Hospital de La Luz

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Ruber Internacional

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Quirónsalud

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Rey Juan Carlos

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

NOT YET RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43204, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

NOT YET RECRUITING

Hospital General Univesitario de Valencia

Valencia, Valencia, Spain

NOT YET RECRUITING

Hospital Universitari Miguel Servet

Zaragoza, Zaragoza, Spain

NOT YET RECRUITING

Hospital del Mar

Barcelona, Spain

NOT YET RECRUITING

Hospital Provincial de Castellón

Castellon, Spain

NOT YET RECRUITING

Institut Català d'Oncologia

Girona, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

Hospital de Terrassa

Terrassa, Spain

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, and DNA samples.

MeSH Terms

Conditions

Neoplasm MetastasisBreast NeoplasmsProstatic NeoplasmsColorectal NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Meritxell Arenas, PhD.

    Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus

    STUDY DIRECTOR

Central Study Contacts

Jorge Joven, Prof.

CONTACT

+34977310300jorge.joven@urv.cat

Meritxell Arenas, PhD.

CONTACT

meritxell.arenas@urv.cat

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

July 6, 2023

Study Start

December 1, 2022

Primary Completion (Estimated)

December 31, 2037

Study Completion (Estimated)

December 31, 2037

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Once decided the repository web address.
Access Criteria
Decided by the principal investigator.

Locations

ES(21)