Actively Recruiting
OligoCare TwiCs Trial Comparing Acute Toxicity of Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment in Oligometastatic Breast, Prostate, NSCLC, and Colorectal Cancer
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-08-01
302
Participants Needed
15
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the use of single-fraction stereotactic body radiotherapy (SBRT) compared to the current standard multiple-fraction SBRT for patients with oligometastatic disease from primary breast, prostate, non-small cell lung cancer (NSCLC), and colorectal cancer. This study aims to determine if a single high-dose radiation session is as safe and effective as multiple treatment sessions. The trial is part of the OligoCare project within the E²-RADIatE platform, which collects real-world data on SBRT in this patient population. Participants will be randomly assigned to receive either single-fraction SBRT or multiple-fraction SBRT. Single-fraction SBRT delivers a high dose of radiation in one visit, with doses ranging from 16 Gy to 34 Gy depending on the metastasis location. Multiple-fraction SBRT spreads the radiation dose over several sessions. The treatment duration varies based on the number of metastases treated. Both approaches target all lesions with radical intent. During the study, participants will be monitored for safety and treatment outcomes, including grade 3 or higher SBRT-related toxicity within 12 months after treatment. Researchers will also assess progression-free survival, overall survival, local control of metastases, and patterns of disease progression over 4.5 years. The trial will involve regular assessments and follow-ups to evaluate these outcomes and the overall impact of the treatments.
CONDITIONS
Brief 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.
- All active cancer lesions are or will be treated with radical intent (surgery or radiotherapy).
- All lesions to be treated with radical radiotherapy are amenable to single-fraction SBRT.
- Concurrent systemic treatment is allowed.
- Written informed consent is provided according to regulations.
You will not qualify if you...
- Lesions judged by the physician to pose high risk of severe toxicity from single-fraction SBRT.
- Pulmonary metastases within 1 cm of the proximal bronchial tree, esophagus, or brachial plexus.
- Metastases within less than 5 mm of any hollow gastrointestinal structures (esophagus, stomach, small bowel, large bowel).
- Metastases within less than 5 mm of the spinal cord, cauda equina, or brachial plexus.
- Metastases larger than 5 cm in diameter.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - From one single visit to a few weeks, depending on the number of treated metastases
Participants receive stereotactic body radiation therapy (SBRT) targeting all active cancer lesions either as a single treatment session or over multiple treatment sessions, depending on randomization and lesion characteristics.
1 to several visits depending on treatment fractionation and number of metastases
Duration - Up to 12 months for toxicity assessment; up to 4.5 years for survival and disease progression monitoring
Participants are monitored for safety and efficacy outcomes including acute toxicity, progression, and survival after completion of SBRT treatment.
Visits scheduled periodically over the follow-up period as per study protocol
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
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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