Cohorts
E²-RADIatE presently comprises 2 innovative cohorts, OligoCare and ReCare.
Despite its almost universal use, the level of evidence supporting radical local treatment in general for oligometastatic patients and stereotactic radiotherapy in particular is low. Uncertainties and variability in practice are therefore huge and it seems highly unlikely or even impossible that these issues will be solved within the traditional framework of prospective randomised trials.
OligoCare is a pragmatic observational cohort study to evaluate radical radiotherapy for patients with oligometastatic disease. The main objective is to identify patient, tumour, diagnostic and treatment characteristics impacting overall survival.
SPRINT
The first primary disease types to be studied are non-small cell lung cancer (NSCLC), breast cancer, prostate cancer and colorectal cancer.
Given the steady enrolment of patients in the OligoCare cohort, the next step was to leverage the OligoCare database to gain further insights on radiotherapy methods by answering research questions in a randomized form using a Trial within Cohorts (TwiCs) methodology. The first TwiCs question is conducted under the alias SPRINT (EORTC 2387).
EORTC’s SPRINT study aims to address this gap by assessing whether single-fraction SBRT is equally effective compared to multi-fraction SBRT. If successful, the study could bring significant benefits to OMD patients, reducing the treatment burden and improving their overall well-being, treatment experience, and quality of life. Moreover, shortening SBRT treatment could minimise interruptions to systemic therapy, potentially improving patient survival.
From a societal perspective, a shift towards single-fraction SBRT would allow more efficient use of limited healthcare resources, creating space to treat more patients, including those with multiple metastases.
Status: Opened for recruitment
ReCare (EORTC 2011-RP) will gather real-world data on patients treated with high-dose re-irradiation for local recurrence, new primary or secondary cancer. With the advent of modern radiotherapy techniques, high-dose re-radiotherapy is more frequently applied, although clinical evidence for its efficacy is scarce and data on safe dose constraints are practically non-existent, apart from very few exceptions.
Therefore, the currently available data does not allow firm assumptions on the safety and efficacy of high-dose re-irradiation, and cannot provide proper evidence to guide clinical practice and inform on consistent standards of care.
Within the current ReCare cohort, re-irradiation is considered with the following general assumptions:
- “Re-irradiation” is defined as a therapeutic dose of radiation delivered to a region/organ which has previously received a therapeutic radiation dose where the summation of the first and the second course carries a risk of a clinical relevant morbidity.
- “High-dose” is defined as re-irradiation to a minimum prescription dose equivalent to 50 Gy EQD2.
Submission of DICOM-RT plans from previous radiotherapy will be encouraged but not mandated. There are no restrictions regarding the techniques applied for re-irradiation treatment, i.e. EBRT, brachytherapy, particle therapy, etc. are all allowed.
