Single‑fraction versus multiple‑fraction SBRT for treating limited metastases (SPRINT)
OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
This trial will test whether a single high‑dose SBRT treatment works as safely and effectively as multiple smaller SBRT treatments for people with limited metastases from breast, prostate, lung, or colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Sex | All |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC Research network |
| Drugs / interventions | radiation |
| Locations | 15 sites (Aalst and 14 other locations) |
| Trial ID | NCT06462963 on ClinicalTrials.gov |
What this trial studies
This randomized TwiCs sub‑study is embedded in the prospective OligoCare cohort and compares single‑fraction stereotactic body radiotherapy (SBRT) to the current multiple‑fraction SBRT standard for oligometastatic breast, prostate, non‑small cell lung, and colorectal cancers. Eligible cohort patients whose all radiotherapy‑treated lesions are amenable to single‑fraction delivery are randomized to receive either one‑time SBRT or the standard multi‑fraction regimen, with concurrent systemic therapy allowed. The primary focus is on acute toxicity and short‑term safety, while efficacy and disease control are collected as secondary outcomes. The trial uses a stepwise consent model typical of Trials Within Cohorts (TwiCs) and is conducted at participating Belgian centers.
Who should consider this trial
Good fit: Ideal candidates are OligoCare cohort members with oligometastatic breast, prostate, NSCLC, or colorectal cancer whose all lesions planned for radical radiotherapy are suitable for single‑fraction SBRT and who can provide informed consent.
Not a fit: Patients whose lesions are not suitable for single‑fraction SBRT, who require alternative local treatments, or who have widespread or uncontrolled disease are unlikely to benefit from the single‑fraction approach tested here.
Why it matters
Potential benefit: If successful, patients could receive effective metastasis‑directed radiotherapy in a single visit, reducing treatment time and potentially lowering overall toxicity and healthcare burden.
How similar studies have performed: A few small prospective studies have reported favorable toxicity profiles and promising efficacy with single‑fraction SBRT, but comparative evidence in broader routine practice remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be treated with radical intent (surgery or radiotherapy). * All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed. * Written informed consent must be given according to ICH/GCP, and national/local regulations. Patients will be consented in a step-wise approach. Step 1 \[both control and experimental arms\]: patients will need to consent to be included and evaluated in E²-RADIatE (that includes the non-interventional OligoCare prospective registry cohort) and to potentially be randomized to future sub-studies for which they are eligible; no further consent will be sought if they are randomized to the SoC (control) arm; Step 2 \[experimental arm only\]: if eligible for the current sub-study and randomized to receive single-fraction SBRT, patients will need to consent to receiving the experimental treatment. Exclusion Criteria: All targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following lesions are systematically excluded: * Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus * Metastases within \< 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel * Metastases within \< 5 mm of the spinal cord, the cauda equina or the brachial plexus * Metastases \> 5 cm in largest diameter.
Where this trial is running
Aalst and 14 other locations
- Onze Lieve Vrouw Ziekenhuis — Aalst, Belgium (Not_yet_recruiting)
- Institut Jules Bordet — Brussels, Belgium (Not_yet_recruiting)
- Universitair Ziekenhuis Gent — Ghent, Belgium (Not_yet_recruiting)
- AZ Groeninge Kortrijk — Kortrijk, Belgium (Not_yet_recruiting)
- Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus — Wilrijk, Belgium (Not_yet_recruiting)
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (Not_yet_recruiting)
- Istituto Clinico Humanitas — Milan, Italy (Not_yet_recruiting)
- Istituto Europeo di Oncologia — Milan, Italy (Not_yet_recruiting)
- Sacro Cuore Hospital — Negrar, Italy (Not_yet_recruiting)
- Policlinico Universitario Campus Bio-Medico- Oncology Center — Roma, Italy (Not_yet_recruiting)
- Universita Di Torino — Torino, Italy (Not_yet_recruiting)
- Radiotherapiegroep Arnhem — Deventer, Netherlands (Not_yet_recruiting)
- Radboudumc - Radboud University Medical Center Nijmegen — Nijmegen, Netherlands (Not_yet_recruiting)
- Inselspital - Inselspital — Bern, Switzerland (Recruiting)
- UniversitaetsSpital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Matthias Guckenberger, MD — Radiation Oncology, University of Zurich, Switzerland
- Study coordinator: Eortc Hq
- Email: eortc@eortc.org
- Phone: +32 2 774 16 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.