About this trial
This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologic confirmation of solid tumour.
Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site
Expected overall survival of greater than 6 months as determined by the treating physician
Suitable for protocol defined SBRT and CRT.
Disqualifiers
Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant/index pain site.
Bone metastasis arising from a small cell or germ cell.
Radionuclide therapy within 30 days of randomization.
Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).
Trial design
Parallel
Treatments tested in this trial
Standard Conventional Radiotherapy
Radiation20Gy in 5 fractions
Stereotactic Body Radiotherapy
Radiation30 or 35Gy in 5 fractions
Treatment groups
Trial outcomes
Primary outcomes
Complete pain response utilizing the Cochran-Mantel-Hanzeal test
Secondary outcomes
Pain response pattern at 3 months: partial, stable or progressive pain
Early (1 month post RT) and late (6 months post RT) CPR and response patterns (partial, stable, and progressive pain);
Re-irradiation rate within the 6-month follow-up period
Incidence of fracture at the radiation target site
Sponsors and contacts
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