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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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. 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.

Group Type EXPERIMENTAL

Preoperative Stereotactic Body Radiotherapy (SBRT)

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No