One radiation dose may be enough to calm cancer bone pain
NCT ID NCT02699697
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tested whether one dose of radiation works as well as two doses for reducing pain from cancer that has spread to the bones. 102 adults with painful bone metastases took part. The goal was to see if a single treatment could provide similar pain relief and reduce the need for repeat treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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102 people
The number who actually took part.
- Start date
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May 2016
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of cancer, not including multiple myeloma * Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites * Eligible treatment sites are: * Weight bearing sites * Pelvis (excluding pubis) * Femur * Sacrum and/or sacroiliac joints * Tibia * Non-weight bearing sites * Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies * Lumbosacral spine * Up to 3 consecutive ribs * Humerus * Fibula * Radius ± ulna * Clavicle * Sternum * Scapula * Pubis If multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia * Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score \< 5 with \>= 60 mg of morphine (or equivalent) per day * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document * Negative pregnancy test at study registration * Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4 weeks before and after the delivery of radiotherapy are allowed, but recording and accounting for this in the statistical analysis is required * Life expectancy of at least 12 weeks as deemed by the treating oncologist * Patients will be eligible for treatment of multiple osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites Exclusion Criteria: * Previous radiotherapy or palliative surgery to the painful site * Metastases to the skull, hands, feet are not eligible treatment sites * Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
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