Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
Completed · Not applicable
Conditions studied: Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone, Pain
In brief
This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.
Key facts
- Study ID
- NCT02699697
- Run by
- Wake Forest University Health Sciences
- People needed
- 102
- Starts
- 2016-05-01
- Expected to finish
- 2025-03-20
- Last updated by the study team
- 2025-12-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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