Metastatic CancerNCT05038124
A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
A study testing Preoperative Stereotactic Body Radiotherapy (SBRT) in people with Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Preoperative Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2021to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
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
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.
- Conditions
- Metastatic Cancer
- Being tested
- Preoperative Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216
- Medical subject headings
- Neoplasm Metastasis, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after preoperative SBRT
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 Jun 2021
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maksim Vaynrub, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038124
- Sponsor's protocol ID
- 21-216
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Vaynrub M, Bartelstein MK, Yu VY, Yamada Y, Gomez DR, Prince DE, Zhang Z, Lobaugh SM, Mueller BA, Bernstein MB, Guttmann DM, Yerramilli D, Yang JT. Preoperative Stereotactic Body Radiotherapy for Metastatic Bone Disease With Impending Fracture: A Nonrandomized Clinical Trial. J Natl Compr Canc Netw. 2026 May 12;24(6):265-270. doi: 10.6004/jnccn.2025.7478.
PubMed 42119606
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05038124
- Acronym / sponsor ID
- 21-216
- Conditions
- Metastatic Cancer
- Keywords
- Skeletal metastases, Stereotactic Body Radiotherapy (SBRT), Surgical Stabilization, Bone cancer, 21-216
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study to evaluate the safety of preoperative stereotactic body radiotherapy (SBRT) with short-interval surgical stabilization.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Stereotactic Body Radiotherapy (SBRT) | Experimental | 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. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Preoperative Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
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.
1 secondary outcome
rate of local control
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42119606Vaynrub M, Bartelstein MK, Yu VY, Yamada Y, Gomez DR, Prince DE, Zhang Z, Lobaugh SM, Mueller BA, Bernstein MB, Guttmann DM, Yerramilli D, Yang JT. Preoperative Stereotactic Body Radiotherapy for Metastatic Bone Disease With Impending Fracture: A Nonrandomized Clinical Trial. J Natl Compr Canc Netw. 2026 May 12;24(6):265-270. doi: 10.6004/jnccn.2025.7478.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maksim Vaynrub, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Stereotactic Body Radiotherapy (SBRT) in people with Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of major wound complications (time frame: 6 weeks after preoperative SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.