The Impact of Radiotherapy on Oligometastatic Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-melanoma skin cancer.

Previous radiotherapy in the same anatomic location.

Presence of vascular collagen disease.

Pregnancy or lactation at the time of inclusion.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: OC-SABR3 interventions
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months after treatment
2

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.

Time frame
5 years after treatment
3

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.

Time frame
5 years after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Investigacio Sanitaria Pere Virgili

Lead sponsor

Hospital Ruber Internacional

Collaborator

Hospital Universitario Rey Juan Carlos

Collaborator

Quirón Madrid University Hospital

Collaborator

Hospital de La Luz

Collaborator

Institut Català d'Oncologia

Collaborator

Hospital Arnau de Vilanova

Collaborator

Hospital Universitari Sant Joan de Reus

Collaborator

Hospital Universitario Virgen Macarena

Collaborator

Hospital Universitario Reina Sofia de Cordoba

Collaborator

Hospital General Universitario de Valencia

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

Complejo Hospitalario Universitario de Albacete

Collaborator

Hospital de Terrassa

Collaborator

Hospital Universitario Ramon y Cajal

Collaborator

Hospital del Mar

Collaborator

Hospital Provincial de Castellon

Collaborator

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator

HM Sanchinarro University Hospital

Collaborator

Hospital Miguel Servet

Collaborator

University Hospital Virgen de las Nieves

Collaborator

Hospital Vall d'Hebron

Collaborator