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.
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.
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.
Parallel
single-fraction SBRT
RadiationSingle-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers a high dose of radiation in a single treatment session to a targeted area, often used for treating small, well-defined tumors. This approach minimizes exposure to surrounding healthy tissues while effectively treating the tumor.
multiple-fraction SBRT
RadiationMultiple-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers high doses of radiation over several treatment sessions to a targeted area, typically used for treating small, well-defined tumors. This method helps to further protect surrounding healthy tissues by spreading the total radiation dose over multiple sessions.
Grade 3+ SBRT-related toxicity
The cumulative incidence of grade 3+ SBRT-related toxicity within 12 months following treatment with radical radiotherapy. This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
Progression free survival (PFS)
defined as the time from the date of randomization to the date of first progression (local, regional or distant) as per local assessment or death.
Overall survival (OS)
defined as the time from the date of randomization to the date of death from any cause.
Local control (LC)
defined as freedom from local metastasis (inside the PTV or prior treated field).
Pattern of progression of primary disease and metastases
Pattern of progression of primary disease and metastases includes local, regional and/or distant progression or recurrence.
Health-related Quality of life (HRQoL)
The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30.
Health-related Quality of life (HRQoL)
The magnitude of change in HRQoL in terms of pain/discomfort from EQ5D-5L questionnaires.
Economic impact of radiation treatment
To document the health economic impact of the two treatments by collecting Use of resources questionnaires during radiation treatment and during follow up.
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