SBRT + Surgical Stabilization for Bone Metastases

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment plan for individuals with bone metastases, where cancer has spread to the bones and may cause fractures. The plan uses a precise form of radiation therapy called stereotactic body radiation therapy (SBRT), followed by surgery to stabilize the bone within a week. Researchers aim to determine if this approach is safe and effective in preventing cancer recurrence in the bones. Suitable candidates have metastatic cancer in specific bones, such as the pelvis or femur, and are potential candidates for surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this treatment approach is safe for patients with bone metastases?

Research shows that stereotactic body radiation therapy (SBRT) is generally well-tolerated by patients. SBRT targets cancer with high doses of radiation very precisely, which helps protect nearby healthy tissues. Studies have found that the risk of serious side effects is low, especially when the radiation dose remains within safe limits. For instance, administering up to 50 Gy to the spine carries a very low risk of harming the spinal cord. Other studies have successfully used SBRT for bone cancer spread without major side effects.

Side effects can vary, with some patients experiencing mild reactions, such as skin redness or fatigue. Overall, SBRT is considered safe for treating bone cancer spread. These findings can reassure prospective trial participants about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of SBRT and surgical stabilization for bone metastases because it offers a potentially more precise and effective approach. Unlike traditional radiation therapy, which might affect a broader area, preoperative SBRT targets the tumor with high doses of radiation in just one to three sessions while sparing the surrounding healthy tissue, especially the surgical path. This precision could lead to better outcomes by reducing tumor size more effectively before surgery. Additionally, the rapid treatment schedule allows for quicker surgical intervention, potentially resulting in faster recovery and improved quality of life for patients.

What evidence suggests that this treatment might be an effective treatment for bone metastases?

Research shows that stereotactic body radiation therapy (SBRT), which trial participants will receive preoperatively, effectively treats cancer that has spread to the bones. Studies indicate that SBRT controls cancer in the treated area 80% to 96% of the time after one year, preventing growth in that area. One study found that 96% of patients experienced pain relief after SBRT for spinal cancer. Another study reported that more than half of the patients felt significant pain relief within three months. These findings suggest that SBRT can help manage cancer and reduce pain for those with bone metastases. ^{1 2 3 5 6}

Who Is on the Research Team?

Maksim Vaynrub, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5415159/

Spine Stereotactic Body Radiotherapy: Indications ... Local control ranges from 80% to 96% at 1 year, and pain response is generally achieved in the majority of patients although high-quality data is lacking. Table ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00002-2/fulltext

Clinical Outcomes Among Patients Treated With ... With median follow-up 19.4 months, 1- and 2-year rates of local control were 94% and 89%, locoregional control was 83% and 67%, progression-free ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07135817

Preoperative Stereotactic Radiotherapy for Treatment of ... The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1053429622000789

Stereotactic Body Radiation Therapy for Spinal Metastases Gerszten et al. reported a pain response rate of 96% after single fraction SBRT with median 19Gy for painful breast cancer spine metastases (n=50 patients). Ito ...

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/41/4/article-p532.xml

Stereotactic body radiotherapy for painful spinal metastases The key finding demonstrates that SBRT achieved significant pain relief in 57.6% of lesions within 3 months. This study adds value by ...

6. trial.medpath.com trial.medpath.com/clinical-trial/36f7abe36bb3c4d8/pilot-study-safety-efficacy-preoperative-radiotherapy-metastatic-bone-disease

A Study of Stereotactic Body Radiotherapy (SBRT ... - MedPath The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week.