About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- single-fraction SBRT
- multiple-fraction SBRT