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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)

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

NCT ID

NCT05038124

First Posted

August 31, 2021

Last Updated

March 24, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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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