Actively Recruiting
OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-08-01
302
Participants Needed
15
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is part of the RP1822-OligoCare study cohort
- All active cancer lesions (primary and oligometastases) have been or will be treated with radical intent (surgery or radiotherapy)
- All lesions to be treated with radical radiotherapy must be suitable for single-fraction SBRT
- Concurrent systemic treatment is allowed
- Written informed consent must be provided according to regulations
- Step 1 consent: inclusion in E²-RADIatE and potential randomization in sub-studies
- Step 2 consent (experimental arm only): consent to receive single-fraction SBRT treatment
You will not qualify if you...
- Lesions judged by physician to pose high risk of severe toxicity with single-fraction SBRT
- Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus, or brachial plexus
- Metastases within less than 5 mm of hollow gastrointestinal structures (esophagus, stomach, small bowel, large bowel)
- Metastases within less than 5 mm of spinal cord, cauda equina, or brachial plexus
- Metastases larger than 5 cm in diameter
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
Not Yet Recruiting
2
Institut Jules Bordet
Brussels, Belgium
Not Yet Recruiting
3
Universitair Ziekenhuis Gent
Ghent, Belgium
Not Yet Recruiting
4
AZ Groeninge Kortrijk
Kortrijk, Belgium
Not Yet Recruiting
5
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus
Wilrijk, Belgium
Not Yet Recruiting
6
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Not Yet Recruiting
7
Istituto Clinico Humanitas
Milan, Italy
Not Yet Recruiting
8
Istituto Europeo di Oncologia
Milan, Italy
Not Yet Recruiting
9
Sacro Cuore Hospital
Negrar, Italy
Not Yet Recruiting
10
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma, Italy
Not Yet Recruiting
11
Universita Di Torino
Torino, Italy
Not Yet Recruiting
12
Radiotherapiegroep Arnhem
Deventer, Netherlands
Not Yet Recruiting
13
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, Netherlands
Not Yet Recruiting
14
Inselspital - Inselspital
Bern, Switzerland, 3010
Actively Recruiting
15
UniversitaetsSpital Zurich
Zurich, Switzerland, 8901
Actively Recruiting
Research Team
E
EORTC HQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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