Comparing one-session and multi-session radiation for cancer spread to a few sites
Compares one radiation session with several sessions in cancer patients with a few spread sites.
Plain-language title generated from the registry record
Registry title: OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
Key facts
- Where
- Florence, Milan, Negrar, Roma, and Torino, ItalySee the 6 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with a few spread-out cancer sites (oligometastatic disease) from breast, prostate, lung (NSCLC) or colorectal cancer, who are in the OligoCare cohort. It compares radiotherapy given in one session with radiotherapy given in several sessions.
- Sex
- All sexes can join.
- Disease stage
- Oligometastatic disease from primary breast, prostate, NSCLC or colorectal cancer. All active cancer sites were or will be treated with radical intent (surgery or radiotherapy). All sites to be treated with radiotherapy must be treatable with single-fraction SBRT.
- Earlier treatment
- Treatment with systemic therapy at the same time is allowed.
Main reasons for not taking part
- Lung metastases within 1 cm (0.4 in) of the main airways, esophagus or brachial plexus
- Metastases within 5 mm of any hollow gut structure (esophagus, stomach, small or large bowel)
- Metastases within 5 mm of the spinal cord, cauda equina or brachial plexus
- Metastases larger than 5 cm (2 in) across
- Treated sites judged by the doctor to carry a risk of severe side effects from single-fraction SBRT
Read by machine on 12 November 2026.
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyContact: EORTC HQNot yet recruiting
- Istituto Clinico HumanitasMilan, ItalyContact: EORTC HQNot yet recruiting
- Istituto Europeo di OncologiaMilan, ItalyContact: EORTC HQNot yet recruiting
- Sacro Cuore HospitalNegrar, ItalyContact: EORTC HQNot yet recruiting
- Policlinico Universitario Campus Bio-Medico- Oncology CenterRoma, ItalyContact: EORTC HQNot yet recruiting
- Universita Di TorinoTorino, ItalyContact: EORTC HQNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- European Organisation for Research and Treatment of Cancer - EORTC
- Trial code
- NCT06462963
- Record updated
- 1 August 2025
- Original description
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.Read full original descriptionShow less
OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
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.
Inclusion: 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: 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.