A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
Running, not enrolling · Not applicable
Conditions studied: Metastatic Cancer
In brief
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.
Key facts
- Study ID
- NCT05038124
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 39
- Starts
- 2021-06-30
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
- Memorial Sloan Kettering Cancer Commack — Commack, New York, United States
- Memorial Sloan Kettering Westchester — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.