prophylactic radiation: Patients will undergo propthylactic radiation on bone metastases
standard of care: Patients will have systemic treatment on the standard of care
Study summary
Radiation therapy is a common treatment for painful bone metastases, proving effective in 1 to 2/3 of cases after 1 to 10 sessions, with stereotactic body radiation therapy (SBRT) likely offering superior results.
Radiation therapy is also used to prevent bone events, although its use is not standardized; the decision to administer it is made by clinicians or through multidisciplinary team (MDT) discussions.
Recently, it has been shown that preventive radiation therapy can reduce the risk of skeletal-related events (SREs) in patients at high risk for bone events.
The objective is to compare active surveillance with preventive radiation therapy in patients at intermediate risk for bone events.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Men or women, 18 years of age or older
* Patients with solid cancer and bone metastases
* Patients with bone lesions considered to be at intermediate risk for skeletal-related events (SINS score between 7 and 12, Mirels 8) or patients with lesions accompanied by Grade 1 epiduritis (Bilsky)
* Enrolled in or covered by a social insurance program
* Patients with an estimated life expectancy of more than 6 months
Exclusion Criteria:
* Hematologic disease
* Patients with a lesion at high risk for skeletal-related events (SINS score of 13 or higher, MIRELS score of 9 or higher, or a multidisciplinary team (MDT) recommendation that surgery is necessary)
* Patients with pain secondary to bone lesions requiring radiation therapy
* Contraindication to radiation therapy due to a history of radiation therapy at the same site or a condition contraindicating radiation therapy
* Pregnant or breastfeeding women
* Contraindication to MRI in cases of spinal lesions; contrast-enhanced CT scan
* Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographic issues, etc.)
* Patients under legal guardianship or conservatorship
* Patients classified as WHO 3 or 4
Primary outcome measure(s)
Bone event — one year rate of bone event in the two arms
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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