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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Cancer Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Stereotactic Body Radiotherapy (SBRT)

Radiation

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.

Primary outcomes

risk of major wound complications

Time frame: 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 outcomes

rate of local control

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Pilot Study to Assess the Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy for the Treatment of Metastatic Disease in Bone Requiring Surgical Stabilization

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2021
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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