Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Best Practice: Given SOC systemic anti-cancer therapy

Biospecimen Collection: Undergo blood sample collection

Bone Metastases Treatment: Given bone modifying agent

Computed Tomography: Undergo CT

Conventional Radiotherapy: Undergo conventional RT

Magnetic Resonance Imaging: Undergo MRI

Patient Observation: Undergo SOC observation

Questionnaire Administration: Ancillary studies

Stereotactic Body Radiation Therapy: Undergo SBRT

Study summary

This phase III trial compares the effect of adding radiation therapy to usual treatment on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms, such as pain (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual treatment for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual treatment may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Eligibility

Primary outcome measure(s)

• Incidence of skeletal-related events (SREs) (Excluding palliative radiation for pain) — From randomization until first SRE up to 24 months
  Gray's test will be used to test for statistically significant difference in the distribution of SRE failure times (Gray 1988), accounting for death as a competing risk. The cause specific Cox proportional hazards model will be used to evaluate the treatment effect and stratification variables (Cox 1972). The analysis will be conducted on an intent-to-treat basis using all randomized patients. Analyses of treatment effect will be performed using the Cox proportional hazard model with the stratification factors as fixed covariates. The adjusted estimate of the treatment hazard ratio with a 95% confidence interval will be provided.

Trial sites (626)

+ 586 more sites — see the full list on the official registry below.

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