Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis (NCT02699697) | Clinical Trial Compass
CompletedNot Applicable
Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
United States102 participantsStarted 2016-05
Plain-language summary
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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, horm…
What they're measuring
1
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)