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
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)