The Impact of Radiotherapy on Oligometastatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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To analyze metastases by radiomics using computed tomography, magnetic resonance, or positron emission tomography images; and
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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 Design
Arms and Interventions
| Arm | 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.
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18 years old or older.
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Up to five metastases located in the bone, lung, node, liver or brain.
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Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 0 or 1.
Exclusion Criteria:
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Non-melanoma skin cancer.
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Previous radiotherapy in the same anatomic location.
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Presence of vascular collagen disease.
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Pregnancy or lactation at the time of inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari Sant Joan de Reus | Reus | Tarragona | Spain | 43204 |
| 2 | Complejo Hospitalario Universitario Albacete | Albacete | Spain | ||
| 3 | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||
| 4 | Hospital del Mar | Barcelona | Spain | ||
| 5 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | ||
| 6 | Institut Català d'Oncologia | Barcelona | Spain | ||
| 7 | Hospital Provincial de Castellón | Castelló de la Plana | Spain | ||
| 8 | Institut Català d'Oncologia | Girona | Spain | ||
| 9 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 10 | Hospital Universitari Arnau de Vilanova | Lleida | Spain | ||
| 11 | Hospital de La Luz | Madrid | Spain | ||
| 12 | Hospital Ruber Internacional | Madrid | Spain | ||
| 13 | Hospital Universitario HM Sanchinarro | Madrid | Spain | ||
| 14 | Hospital Universitario Quirónsalud | Madrid | Spain | ||
| 15 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
| 16 | Hospital Universitario Rey Juan Carlos | Madrid | Spain | ||
| 17 | Hospital Universitario Virgen Macarena | Sevilla | Spain | ||
| 18 | Hospital de Terrassa | Terrassa | Spain | ||
| 19 | Hospital Clínico Universitario de Valencia | Valencia | Spain | ||
| 20 | Hospital General Univesitario de Valencia | Valencia | Spain | ||
| 21 | Hospital Universitari Miguel Servet | Zaragoza | Spain |
Sponsors and Collaborators
- Institut Investigacio Sanitaria Pere Virgili
- HM Sanchinarro University Hospital
- Hospital Ruber Internacional
- Hospital Universitario Rey Juan Carlos
- Quirón Madrid University Hospital
- Hospital de La Luz
- Institut Català d'Oncologia
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Hospital Vall d'Hebron
- Hospital Arnau de Vilanova
- Hospital Universitari Sant Joan de Reus
- Hospital Miguel Servet
- Hospital Universitario Virgen Macarena
- Hospital Universitario Reina Sofia de Cordoba
- University Hospital Virgen de las Nieves
- Hospital General Universitario de Valencia
- Hospital Clínico Universitario de Valencia
- Complejo Hospitalario Universitario de Albacete
- Hospital de Terrassa
- Hospital Universitario Ramon y Cajal
- Hospital del Mar
- Hospital Provincial de Castellon
Investigators
- Study Director: Meritxell Arenas, PhD., Universitat Rovira i Virgili, Hospital Universitari Sant Joan de Reus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OC-SABR