A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cance… (NCT05038124) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
United States39 participantsStarted 2021-06-30
Plain-language summary
The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.
Who can participate
Age range
18 Years
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 metastatic cancer with radiologic evidence of skeletal metastases
* Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis
* Age at enrollment ≥18 years
* Life expectancy \>3 months
* Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site
* Surgical candidate, as determined by the treatment team
* Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity.
* Must agree to practice an effective contraceptive method (for those with reproductive potential)
Exclusion Criteria:
* Prior radiotherapy to the treatment site
* Prior surgery involving the treatment site
* Tumor volume or distribution precluding effective SBRT
* Expected skin dose at the operative site ≥9 Gy
* Imminently impending fracture requiring immediate stabilization surgery
* Involvement of proximal tibia
* Autoimmune connective tissue disorder
* Administration of radiosensitizing medication 3 days before, during, and 3 days after RT
* Active infection
* Absolute neutrophil count \<1.0
* Pregnancy
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.