Impact of Prophylactic Bone Radiation Therapy in Patients With Bone Metastases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prophylactic radiation, standard of care.
- Who it may be relevant to
- Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Prophylactic Bone Radiation Therapy on Morbidity and Mortality in Patients With Asymptomatic Bone Metastases and an Intermediate Risk of Bone Events.
Overview
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.
Interventions
- Radiation prophylactic radiation
Patients will undergo propthylactic radiation on bone metastases - Drug standard of care
Patients will have systemic treatment on the standard of care
Primary outcome measures
- Bone event [Time frame: one year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Institut de Cancérologie de Lorraine — Nancy
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT07733193 · CHB25.03 · 2025-A01328-41