Impact of Prophylactic Bone Radiation Therapy in Patients With Bone Metastases.
ConditionBone Metastases
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Henri Becquerel
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
prophylactic radiation
RadiationPatients will undergo propthylactic radiation on bone metastases
standard of care
DrugPatients will have systemic treatment on the standard of care
Treatment groups
154 Participants
are divided into 2 treatment groupsGroup A: Standard armActive comparator 1 intervention
Group B: Prophylactic radiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bone event
rate of bone event in the two arms
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: