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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05038124
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. risk of major wound complications [ Time Frame: 6 weeks after preoperative SBRT ]
    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.


Secondary Outcome Measures :
  1. rate of local control [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Concomitant administration of radiosensitizing medication
  • Active infection
  • Absolute neutrophil count <1.0
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038124


Contacts
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Contact: Maksim Vaynrub, MD 212-639-7038 vaynrubm@mskcc.org
Contact: Meredith Bartelstein, MD 212-639-8684

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Maksim Vaynrub, MD    212-639-7038      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Maksim Vaynrub, MD    212-639-7038      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Maksim Vaynrub, MD    212-639-7038      
United States, New York
Memorial Sloan Kettering Cancer Commack Recruiting
Commack, New York, United States, 11725
Contact: Maksim Vaynrub, MD    212-639-7038      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Maksim Vaynrub, MD    212-639-7038      
Memorial Sloan Kettering Cancer Center (All protocol activities) Recruiting
New York, New York, United States, 10065
Contact: Makskim Vaynrub, MD    212-639-7038      
Contact: Meredith Bartelstein, MD    212-639-8684      
Principal Investigator: Maksim Vaynrub, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Maksim Vaynrub, MD    212-639-7038      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Maksim Vaynrub, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05038124    
Other Study ID Numbers: 21-216
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Skeletal metastases
Stereotactic Body Radiotherapy (SBRT)
Surgical Stabilization
Bone cancer
21-216
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes