A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Metastatic Cancer

Treatments: Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05038124

21-216

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Preoperative Stereotactic Body Radiotherapy (SBRT)

Experimental group

Description:

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. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed.

Treatment:

Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)