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

Metastatic Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05038124
• Other study ID #: 21-216
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• Preoperative Stereotactic Body Radiotherapy (SBRT)
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	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 Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All protocol activities)	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of major wound complications	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.	6 weeks after preoperative SBRT
Secondary	rate of local control	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center