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

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative Stereotactic Body Radiotherapy (SBRT)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Memorial Sloan Kettering Cancer CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Memorial Sloan Kettering Cancer Center (All protocol activities)Recruiting
  • Memorial Sloan Kettering NassauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative Stereotactic Body Radiotherapy (SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

rate of local control
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.

Full Information

First Posted
August 31, 2021
Last Updated
March 24, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05038124
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Stereotactic Body Radiotherapy (SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Preoperative Stereotactic Body Radiotherapy (SBRT)
Intervention Description
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 Measure Information:
Title
risk of major wound complications
Description
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.
Time Frame
6 weeks after preoperative SBRT
Secondary Outcome Measure Information:
Title
rate of local control
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Email
vaynrubm@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Bartelstein, MD
Phone
212-639-8684
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Facility Name
Memorial Sloan Kettering Cancer Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038
Facility Name
Memorial Sloan Kettering Cancer Center (All protocol activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makskim Vaynrub, MD
Phone
212-639-7038
First Name & Middle Initial & Last Name & Degree
Meredith Bartelstein, MD
Phone
212-639-8684
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Vaynrub, MD
Phone
212-639-7038

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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