Clinical trial NCT05038124: A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Keywords: Skeletal metastases
Stereotactic Body Radiotherapy (SBRT)
Surgical Stabilization
Bone cancer
21-216
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: risk of major wound complications
timeFrame: 6 weeks after preoperative SBRT
Secondary outcomes:
measure: rate of local control
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Maksim Vaynrub, MD
role: PRINCIPAL_INVESTIGATOR
References: