The Impact of Radiotherapy on Oligometastatic Cancer

Recruiting

• Conditions: Metastatic Colorectal Cancer; Metastasis; Metastatic Breast Cancer; Metastatic Prostate Cancer; Metastatic Lung Cancer

• Registration Number: NCT05933876
• Lead Sponsor: Institut Investigacio Sanitaria Pere Virgili

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.

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2037-12-31
• Study Completion: 2037-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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.
SABR toxicities	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.
Radiological rate	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.

Trial Locations

Locations (20)

Hospital Universitari Sant Joan de Reus; 🇪🇸 Reus, Tarragona, 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; 🇪🇸 Girona, Spain

Hospital Provincial de Castellón; 🇪🇸 Castelló de la Plana, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital de La Luz; 🇪🇸 Madrid, Spain

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