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Radiation Therapy

SBRT + Surgical Stabilization for Bone Metastases

N/A

Waitlist Available

Led By Maksim Vaynrub, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site

Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether a combination of radiation and surgery can effectively treat cancer in the bones, and whether this treatment approach can prevent cancer from returning.

Who is the study for?

This trial is for adults over 18 with cancer that has spread to their bones, who are at risk of bone fractures due to the disease. They must be able to undergo surgery, give informed consent, use effective birth control if needed, and have a life expectancy over 3 months. Excluded are those with prior treatments or surgeries in the affected area, high skin dose risks from radiation, immediate fracture risks, certain autoimmune diseases, active infections or low neutrophil counts.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) followed by surgical stabilization within one week on patients with bone metastases. The goal is to see if this treatment prevents cancer from returning to the treated bone area.See study design

What are the potential side effects?

Potential side effects include typical reactions related to radiotherapy such as skin irritation at the treatment site, fatigue, possible pain or discomfort post-treatment. Surgical complications could also occur like infection at the surgery site or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can undergo radiation treatment without moving the affected body part.

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My cancer has spread to my bones, confirmed by scans.

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My treatment targets bones in my arm, leg, or pelvis.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

risk of major wound complications

Secondary outcome measures

rate of local control

Trial Design

1Treatment groups

Experimental Treatment

Group I: Preoperative Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,281 Total Patients Enrolled

Maksim Vaynrub, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Preoperative Stereotactic Body Radiotherapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05038124 — N/A

Cancer Research Study Groups: Preoperative Stereotactic Body Radiotherapy (SBRT)

Cancer Clinical Trial 2023: Preoperative Stereotactic Body Radiotherapy (SBRT) Highlights & Side Effects. Trial Name: NCT05038124 — N/A

Preoperative Stereotactic Body Radiotherapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038124 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being enrolled in this research effort?

"Data from clinicaltrials.gov indicates that the study is currently in a recruitment phase, after being first posted on July 30th 2021 and last updated 5th of July 2022."

Answered by AI

How many facilities are responsible for administering this clinical trial?

"Enrolment sites for this clinical trial include Memorial Sloan Kettering Westchester in Harrison, MSK Basking Ridge in Basking Ridge, and Commack Cancer Center; plus an additional 8 locations."

Answered by AI

What is the total sample size for this trial?

"Affirmative. According to the clinicaltrials.gov records, this clinical trial is presently recruiting individuals for participation. It was first posted on July 30th 2021 and updated most recently on July 5th 2022; 34 patients are needed from 8 different medical locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038124.