Metastatic Cancer
Conditions
Keywords
Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216
Brief 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.
Interventions
Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| risk of major wound complications | 6 weeks after preoperative SBRT | Major wound complications are defined as reoperation for wound revision, clinically diagnosed surgical site infection, readmission for wound care, or prolonged (\>3 weeks postoperatively) active wound care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of local control | 1 year | Failure of local control is defined as a new lesion within the radiation or surgical field, significant progression of an existing lesion, or reoperation or reirradiation due to tumor progression. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaksim Vaynrub, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed