NCT06462963 OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
| NCT ID | NCT06462963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 302 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2029-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 302 participants in total. It began in 2025-04-15 with a primary completion date of 2029-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT. The main question/hypothesis this clinical trial aims to answer is: \- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy. Patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.
Eligibility 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.
Contact & Investigator
Matthias Guckenberger, MD
PRINCIPAL INVESTIGATOR
Radiation Oncology, University of Zurich, Switzerland
Frequently Asked Questions
Who can join the NCT06462963 clinical trial?
This trial is open to participants of all sexes, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06462963 currently recruiting?
Yes, NCT06462963 is actively recruiting participants. Contact the research team at eortc@eortc.org for enrollment information.
Where is the NCT06462963 trial being conducted?
This trial is being conducted at Aalst, Belgium, Brussels, Belgium, Ghent, Belgium, Kortrijk, Belgium and 11 additional locations.
Who is sponsoring the NCT06462963 clinical trial?
NCT06462963 is sponsored by European Organisation for Research and Treatment of Cancer - EORTC. The principal investigator is Matthias Guckenberger, MD at Radiation Oncology, University of Zurich, Switzerland. The trial plans to enroll 302 participants.
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