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

Not Applicable

Active, not recruiting

• Conditions: Metastatic Cancer

• Registration Number: NCT05038124
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

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