Single‑fraction versus multiple‑fraction SBRT for treating limited metastases (SPRINT)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Inselspital - Inselspital
  Bern, Switzerland Recruiting
• UniversitaetsSpital Zurich
  Zurich, Switzerland Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.