OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
Recruiting · NCT06462963 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
multiple-fraction SBRTsingle-fraction SBRT
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
30 locations listed.
- Onze Lieve Vrouw Ziekenhuis - Aalst, Belgium
- Onze Lieve Vrouw Ziekenhuis - Aalst, Belgium
- Inselspital - Inselspital - Bern, Switzerland
- Inselspital - Inselspital - Bern, Switzerland
- Institut Jules Bordet - Brussels, Belgium
- Institut Jules Bordet - Brussels, Belgium
- Radiotherapiegroep Arnhem - Deventer, Netherlands
- Radiotherapiegroep Arnhem - Deventer, Netherlands
- Azienda Ospedaliero-Universitaria Careggi - Florence, Italy
- Azienda Ospedaliero-Universitaria Careggi - Florence, Italy
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Universitair Ziekenhuis Gent - Ghent, Belgium
- AZ Groeninge Kortrijk - Kortrijk, Belgium
- AZ Groeninge Kortrijk - Kortrijk, Belgium
- Istituto Clinico Humanitas - Milan, Italy
- Istituto Europeo di Oncologia - Milan, Italy
- Istituto Clinico Humanitas - Milan, Italy
- Istituto Europeo di Oncologia - Milan, Italy
- Sacro Cuore Hospital - Negrar, Italy
- Sacro Cuore Hospital - Negrar, Italy
- Radboudumc - Radboud University Medical Center Nijmegen - Nijmegen, Netherlands
- Radboudumc - Radboud University Medical Center Nijmegen - Nijmegen, Netherlands
- Policlinico Universitario Campus Bio-Medico- Oncology Center - Roma, Italy
- Policlinico Universitario Campus Bio-Medico- Oncology Center - Roma, Italy
- Universita Di Torino - Torino, Italy
- Universita Di Torino - Torino, Italy
- Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus - Wilrijk, Belgium
- Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus - Wilrijk, Belgium
- UniversitaetsSpital Zurich - Zurich, Switzerland
- UniversitaetsSpital Zurich - Zurich, Switzerland