SBRT + Surgical Stabilization for Bone Metastases

Recruiting at 9 trial locations

Overseen By Maksim Vaynrub, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Radiosensitizing medications

Disqualifiers: Prior radiotherapy, Prior surgery, Autoimmune disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

39 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take radiosensitizing medications (drugs that make cancer cells more sensitive to radiation) 3 days before, during, and 3 days after the radiation therapy.

What data supports the effectiveness of the treatment Preoperative Stereotactic Body Radiotherapy (SBRT) for bone metastases?

Research shows that SBRT, a precise form of radiation therapy, can improve survival rates and control cancer spread in patients with bone metastases from solid tumors like breast, prostate, and lung cancer. It is effective in managing bone metastases, potentially leading to better outcomes when combined with standard treatments. ^{1 2 3 4 5}

Is SBRT safe for treating bone metastases?

Research shows that stereotactic body radiotherapy (SBRT) is generally safe for treating bone metastases, including spinal metastases. Studies have evaluated its safety and compared it to conventional radiation therapy, indicating it is a viable option for patients. ^{1 6 7 8 9}

How is the treatment SBRT + Surgical Stabilization for Bone Metastases different from other treatments?

This treatment is unique because it combines preoperative stereotactic body radiotherapy (SBRT) with surgical stabilization, allowing for high-dose radiation to be delivered before surgery. This approach can lead to faster recovery, earlier pain relief, and quicker return to other cancer treatments compared to traditional methods where radiotherapy is given after surgery. ^{6 10 11 12 13}

Research Team

Maksim Vaynrub, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can give consent myself or through a legal representative if I'm unable to make decisions.

Life expectancy >3 months

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

Exclusion Criteria

My tumor cannot be effectively treated with focused radiation due to its size or spread.

The skin at my surgery area is expected to receive a high dose of radiation.

I have had surgery on the area being considered for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive preoperative stereotactic body radiotherapy (SBRT) with a biologically effective dose of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction

1 week

Surgical Stabilization

Surgical stabilization is performed within 1 week of completion of radiotherapy, with pathologic specimens obtained intraoperatively for analysis

1 week

Follow-up

Participants are monitored for major wound complications and local control of the disease

6 weeks

Long-term Follow-up

Participants are monitored for local control failure, defined as new lesions or significant progression within the radiation or surgical field

1 year

Treatment Details

Interventions

• Preoperative Stereotactic Body Radiotherapy (SBRT)

Trial Overview 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.

Participant Groups

Group I: Preoperative Stereotactic Body Radiotherapy (SBRT) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

This multicenter randomized phase III trial aims to determine if combining Stereotactic Body Radiation Therapy (SBRT) with standard systemic treatment improves progression-free survival in patients with solid tumors and up to 3 bone-only metastases, with a total of 196 patients expected to be enrolled over 4 years.

The primary goal is to assess progression-free survival at 1 year, while secondary outcomes will evaluate local control, cancer-specific survival, quality of life, and pain management, highlighting the potential for SBRT to enhance patient outcomes by controlling bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). Thureau, S., Marchesi, V., Vieillard, MH., et al.[2021]

In a study of 434 patients treated with stereotactic body radiation therapy (SBRT) for bone metastases, a biologically effective dose (BED10) of 50 or higher was linked to better local control of oligometastatic lesions, while larger planning target volumes (PTV) for nonspine lesions predicted worse local control.

Factors such as prostate cancer histology, a performance status of 0 to 1, and a metastasis-free interval of 2 years or more were associated with improved progression-free survival (PFS) and overall survival (OS), highlighting the importance of patient selection in optimizing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Treatment Factors Associated With Improved Local Control and Survival in Oligometastatic Bone Disease: Results From a Large Single-Institution Experience Using Stereotactic Body Radiation Therapy. Thomas, MC., Chen, YH., Fite, E., et al.[2022]

Stereotactic body radiotherapy (SBRT) for vertebral metastases showed high efficacy, with a local tumor control rate of 83.9% at two years and a median overall survival of 19.5 months among 301 patients treated across eight centers.

The treatment was generally safe, with low rates of adverse events; only 4.1% of patients experienced progression of vertebral compression fractures, and no cases of radiation-induced myelopathy were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of stereotactic body radiotherapy as primary treatment for vertebral metastases: a multi-institutional analysis. Guckenberger, M., Mantel, F., Gerszten, PC., et al.[2022]

Stereotactic body radiotherapy (SBRT) for spinal metastases shows high local control rates exceeding 80% at one year, with effective pain management and low toxicity when strict dose constraints are followed.

There is no clear superiority between single and multifraction regimens in terms of local control and pain relief, but hypofractionated treatments may offer advantages in reducing toxicity compared to single-fraction regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. Huo, M., Sahgal, A., Pryor, D., et al.[2022]

Stereotactic body radiation therapy (SBRT) significantly improved complete pain response rates at 3 months for patients with painful bone metastases compared to conventional external beam radiation therapy (cEBRT), with a high certainty of evidence from six randomized controlled trials.

SBRT also reduced local progression rates, indicating it may be more effective in managing bone metastases, although it was associated with increased pain flare rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy versus conventional external beam radiation therapy for painful bone metastases: A systematic review and meta-analysis of randomized trials. Lee, CC., Soon, YY., Cheo, T., et al.[2022]

Stereotactic body radiotherapy (SBRT) demonstrated high local control rates for spinal metastasis, with 83% at 1 year and 71% at 2 years, and a median overall survival of 30.6 months among 26 patients with 32 lesions.

The treatment was found to be safe, with only 16% of patients experiencing acute pain flare, which was manageable, and no cases of radiation-induced myelopathy reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. Yeung, WME.[2021]

Stereotactic body radiotherapy (SBRT) is an emerging treatment for spinal metastases, allowing for the delivery of high doses of radiation to improve tumor control and provide relief from symptoms.

SBRT is particularly beneficial for patients with complex cases, such as those who have previously received radiation at the same site or have tumors that are resistant to conventional treatments, and can be used alongside other therapies like spinal decompression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy: an emerging treatment for spinal metastases. Dahele, M., Fehlings, MG., Sahgal, A.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy of bone metastases in oligometastatic disease: prognostic factors of oncologic outcomes. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Metastases in Long Bones. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient and Treatment Factors Associated With Improved Local Control and Survival in Oligometastatic Bone Disease: Results From a Large Single-Institution Experience Using Stereotactic Body Radiation Therapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of stereotactic body radiotherapy as primary treatment for vertebral metastases: a multi-institutional analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy is effective salvage therapy for patients with prior radiation of spinal metastases. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy versus conventional external beam radiation therapy for painful bone metastases: A systematic review and meta-analysis of randomized trials. [2022]

9. China pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Spine Oligometastases: A Multicentre Retrospective Study From the Italian Association of Radiotherapy and Clinical Oncology (AIRO). [2023]

11. England pubmed.ncbi.nlm.nih.gov

Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: a randomized trial (BLEND RCT) using the Trials within Cohorts (TwiCs) design. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Consensus Contouring Guidelines for Postoperative Stereotactic Body Radiation Therapy for Metastatic Solid Tumor Malignancies to the Spine. [2022]