NCT05038124

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2021Jun 2027

Study Start

First participant enrolled

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

5.9 years

First QC Date

August 31, 2021

Last Update Submit

March 3, 2026

Conditions

Metastatic Cancer

Keywords

Skeletal metastasesStereotactic Body Radiotherapy (SBRT)Surgical StabilizationBone cancer21-216

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • rate of local control

    1 year

Study Arms (1)

Preoperative Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

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.

Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)

Interventions

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.

Preoperative Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisBone Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Officials

  • Maksim Vaynrub, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

June 30, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)