EORTC 2387-SPRINT: The first pan-European TwiCs clinical trial activated
The EORTC 2387-SPRINT clinical trial, the first pan-European Trial within Cohorts (TwiCs) targeting patients with oligometastatic disease (OMD), has officially activated its first two centres. This milestone marks a significant step forward in evaluating treatment strategies for patients with OMD from primary breast, prostate, lung, and colorectal cancers.
OMD refers to a state in which cancer has spread to a limited number of organs. Current international guidelines recommend treatment with radical local therapies like stereotactic body radiotherapy (SBRT).
However, while SBRT is typically delivered in multiple sessions (3-5 per metastasis, amounting to 15-25 sessions in total), emerging evidence suggests that single-fraction SBRT may be equally effective while reducing treatment burden. The SPRINT study aims to assess whether single-fraction SBRT can match the effectiveness of multi-fraction SBRT, potentially improving patient experience and quality of life.
The importance of TwiCs methodology
SPRINT is the first pan-European Trial within Cohorts (TwiCs) study, embedded within the OligoCare cohort of the E²RADIatE platform. The TwiCs design aims to overcome challenges associated with classical clinical trials. It involves identifying eligible patients from a large observational cohort, randomly selecting some to be approached for an intervention, and comparing their outcomes with those of eligible patients not selected for the intervention, who receive usual care. This approach streamlines recruitment, reduces disappointment in patients and produces more generalizable results compared to a classic randomized controlled trial.
To date, over 80 TwiCs studies have been conducted worldwide, primarily at the national level in the Netherlands and UK, with none yet applied internationally in oncology.
Building on the success of the OligoCare prospective cohort, which has enrolled over 3,300 patients across 60 European institutions, this study represents a unique opportunity to test this innovative and resource-sparing trial methodology at a broader, international scale.
Achieving this milestone will not only advance scientific knowledge by validating the TwiCs approach in a diverse, multi-country setting, but also pave the way for more efficient, patient-centred research. It has the potential to accelerate the generation of robust clinical evidence, improve treatment personalization, and enhance outcomes for cancer patients across Europe.
Next Steps in the SPRINT trial
The EORTC SPRINT study will enrol 302 patients across 25 leading cancer centres in nine European countries over a 32-month period. The study’s primary objective is to compare single-fraction and multi-fraction SBRT based on the incidence of grade 3 or higher SBRT-related toxicity within 12 months. Secondary objectives include assessing progression-free survival (PFS), overall survival (OS), local control (LC), quality of life, patterns of disease progression, and healthcare resource utilization.
Additional centres are expected to join the study in the coming months, accelerating efforts to improve outcomes for patients across Europe.
SPRINT is supported by the Rising Tide Foundation for Cancer Research.
E²RADIatE is supported by WBA.