NEWS

Brussels, 5 November 2024 – Rising Tide Foundation for Clinical Cancer Research (RTFCCR) has awarded a grant to the EORTC 2387-SPRINT academic clinical study, the first pan-European Trial within Cohorts (TwiCs) targeting patients with oligometastatic disease (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. International guidelines indicate these cases are treated with radical local therapies like stereotactic body radiotherapy (SBRT). Currently, SBRT for OMD is typically delivered in multiple sessions (3-5 per metastasis, totaling 15-25 sessions), which complicates its integration with other treatments and increases the burden on radiation therapy resources and patient compliance. Although some Phase II clinical trials have shown that single-fraction SBRT is safe with no significant toxicity and maintains local control of metastases, its use in routine practice remains rare.

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.

“The SPRINT study has the potential to significantly enhance the treatment landscape for patients with oligometastatic disease. SPRINT builds on the existing OligoCare registry and represents a true methodological innovation, being the first international Trial within Cohorts (TwiCs) in radiation oncology optimising access for patients to new forms of treatment” said Denis Lacombe, MD, EORTC CEO. “We are grateful to have RTFCCR, a long-term partner of EORTC, supporting this trial, bringing us closer to improving both patient outcomes and healthcare efficiency across Europe.”

“Such an excellent design to change standard of care based on the proposed endpoints and focused on providing more effective and less toxic (economically and socially less toxic) treatment options, is a patient driven clinical trial we are proud of supporting” said Alexandre Alencar, MD, Head of Cancer Research Programs, Rising Tide Foundation for Clinical Cancer Research.

The study 

The EORTC SPRINT study is a randomised, multicentre phase II non-inferiority study designed to compare single-fraction SBRT to multiple-fraction SBRT, based on the cumulative incidence of grade 3 or higher SBRT-related toxicity within 12 months of starting radiotherapy. The study follows a TwiCs design embedded within the OligoCare cohort study, part of the E²RADIatE platform (a joint initiative of EORTC and ESTRO). The OligoCare study has enrolled over 3,000 patients from 58 European institutions. The TwiCs approach is intended to address limitations of classical trial designs by leveraging real-world clinical data. 

The TwiCs paradigm involves identifying eligible patients from a large observational cohort, randomly selecting some to be approached for an intervention. Their outcomes are compared with those of eligible patients not selected, receiving usual care. 

The SPRINT study will enrol 302 patients over a period of 32 months, with participation from 25 leading cancer centres across nine European countries.  

Secondary objectives include comparing progression-free survival (PFS), overall survival (OS), local control (LC), quality of life, and patterns of disease progression in both primary and metastatic sites. The study will also assess resource utilization to determine potential efficiency gains. 

“The SPRINT trial represents an important step forward in optimising treatment for patients with oligometastatic disease,” said Prof. Matthias Guckenberger, Study Coordinator of the EORTC SPRINT trial. “By comparing single- and multiple-fraction SBRT, we hope to provide evidence that can improve both patient outcomes and the efficiency of care, ultimately reducing the burden on patients and healthcare systems alike.”  

The study is expected to open by December 2024. 

Notes to the Editors

About the Rising Tide Foundation for Clinical Cancer Research 

Rising Tide Foundation for Clinical Cancer Research (RTFCCR) is a charitable, non-profit organization established in 2010 and located in Schaffhausen Switzerland.  RTFCCR’s primary consideration in granting support is given to truly innovative, unique, patient-centered clinical research.  The long-term ambition of the foundation is to optimize partnerships and attract the best in Phase I to Phase III clinical trials that aim to bring maximum patient benefit in the shortest time possible. With patients at the core of the mission, the foundation strives to support clinical trials resulting in the creation of less toxic therapeutic approaches, better disease burden management, earlier cancer detection, and innovative prevention strategies that will lead to increased quality of life and survival. 

www.risingtide-foundation.org  

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