SBRT for Bone Cancer

Overseen By Claudia Roldan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Systemic therapies

Disqualifiers: Hematologic malignancies, Epidural tumor, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of radiation therapy called stereotactic body radiation therapy (SBRT) for cancer that has spread to the bones, including the spine. The study aims to evaluate SBRT's effectiveness for two groups: those needing re-irradiation and those with limited cancer spread (up to three sites). Participants must have bone cancer confirmed by a doctor, with tumors no larger than about 2.5 inches, and should not have had another active cancer in the last two years. This trial may suit individuals with bone cancer, particularly if it has spread to the spine or other areas, and who meet the specific criteria. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot be on active systemic therapies (treatments that affect the entire body) at the same time as the trial. Hormonal therapies are allowed.

What prior data suggests that Stereotactic Body Radiation Therapy (SBRT) is safe for treating bone cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is generally manageable for patients with bone cancer spread. Past studies found that SBRT relieves pain more effectively than traditional radiation treatments for those with painful bone cancer spread, indicating that the treatment is both effective and safe.

One study examined SBRT for cancer spread to the spine and confirmed its efficacy. Although these studies focus on different body areas, they consistently demonstrate that SBRT can safely and effectively treat bone-related cancer issues.

Overall, these findings suggest that SBRT is a promising option for treating cancer that has spread to the bones, with manageable safety and side effects based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for bone cancer?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for bone cancer because it offers a precise, targeted approach that minimizes damage to surrounding healthy tissue. Unlike traditional radiation therapy, which can affect both cancerous and non-cancerous areas, SBRT uses advanced imaging and robotic technology to deliver high doses of radiation directly to the tumor with pinpoint accuracy. This precision not only reduces side effects but also allows for shorter treatment times, which can significantly improve patient comfort and convenience. Additionally, SBRT is versatile, catering to both re-irradiation of previously treated sites and treating up to three new metastatic sites, making it a promising option for complex cases.

What evidence suggests that SBRT might be an effective treatment for bone cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats bone metastases, which occur when cancer spreads to the bones. In this trial, participants will receive SBRT for either re-irradiation to metastatic disease or oligometastatic disease. One study found that patients who received SBRT for painful bone metastases experienced better pain relief three months after treatment compared to those who had regular radiation therapy. Another study found that SBRT effectively controls cancer in the treated area and relieves symptoms with few side effects. For cancer that has spread to the spine, current evidence confirms that SBRT is an effective treatment option. Overall, SBRT has shown promising results for easing pain and controlling cancer in bones. ^{1 4 5 6 7}

Who Is on the Research Team?

Tracy Balboni, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with bone cancer that has spread to the spine or other bones, but not more than three places. They should be in good enough health to sign consent and have a life expectancy of over 3 months. Pregnant women, those with blood cancers, recent other cancers (except certain skin cancers and cervical cancer in situ), or who can't lie still for treatment are excluded.

Inclusion Criteria

My cancer spread to bones is less than 6 cm and affects no more than 3 spine bones.

I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 2 years.

My cancer has spread to 3 or fewer places, including where it started.

Exclusion Criteria

I have received radiation therapy with a dose higher than 100 Gy2.

I am currently receiving treatment for my cancer that involves medication taken by mouth or injection.

I can't stay still for treatments even with medication for anxiety or pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiation Therapy (SBRT) to up to 3 sites of disease occurring in the bone or spine

6 weeks

Treatments delivered on a dedicated stereotactic linear accelerator

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

3 months

Follow-up visits for quality of life assessments

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview The study tests Stereotactic Body Radiation Therapy (SBRT) using a Stereotactic Linear Accelerator on patients with limited metastatic bone disease. It aims to see if this targeted radiation therapy is effective for treating small areas where cancer has spread to the bones.

How Is the Trial Designed?

Group I: Re-irradiation to Metastatic Disease Experimental Treatment 2 Interventions

Stereotactic Body Radiation Therapy (SBRT) to site(s) of disease occurring in the bone or spine * Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top. * Dosage will be determined by physician

Group II: Oligometastatic Disease Experimental Treatment 2 Interventions

Stereotactic Body Radiation Therapy (SBRT)to up to 3 sites of disease occurring in the bone or spine * Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top. * Dosage will be determined by physician

Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

In a study of 84 patients with spinal metastases treated with stereotactic body radiotherapy (SBRT), targeting only the lesion (LO) showed similar tumor control and pain reduction compared to targeting the full vertebral body (FVB), indicating that LO may be a sufficient treatment approach.

There were no significant differences in the rates of compression fractures between the LO and FVB groups, suggesting that both treatment strategies are equally safe in terms of fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Clinical Outcomes Stratified by Target Delineation for Patients Undergoing Stereotactic Body Radiotherapy for Spinal Metastases. Attiah, M., Sandler, K., Medina, R., et al.[2020]

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) offers a promising treatment option for painful bone metastases, delivering high doses of radiation accurately over one to a few sessions, which may improve patient outcomes compared to conventional radiotherapy.

SBRT is particularly beneficial for treating tumors that are usually resistant to radiation, although it is important to consider potential toxicity to surrounding healthy tissues and the patterns of local treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in the management of painful bone metastases. Jhaveri, P., Teh, BS., Bloch, C., et al.[2008]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

In a study of 93 patients with prostate cancer receiving stereotactic body radiotherapy (SBRT) for spinal metastases, local control rates were very high, with 99% at 1 year and 95% at 2 years for hormone-sensitive prostate cancer (HSPC), but lower for castrate-resistant prostate cancer (CRPC) at 94% and 78%, respectively.

The overall survival rates were significantly better for patients with HSPC, at 98% and 95% at 1 and 2 years, compared to 79% and 65% for those with CRPC, indicating that hormone sensitivity impacts both local control and survival outcomes after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. Abugharib, A., Zeng, KL., Tseng, CL., et al.[2022]

A comprehensive risk analysis of the paraspinal SBRT workflow identified 74 potential failure modes across various phases, with treatment planning being a significant source of safety concerns.

The highest risks were linked to inadequate evaluation of previous radiotherapy, incorrect imaging registration, and undetected patient movement, prompting the implementation of targeted remedies like staff education and improved imaging protocols to enhance treatment safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. Lee, S., Lovelock, DM., Kowalski, A., et al.[2021]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

Stereotactic radiotherapy (SBRT) shows promise in improving pain relief and local control in patients with bone metastases, with higher pain response rates compared to conventional radiotherapy, based on a systematic review of 57 studies involving 3995 patients.

Despite the positive findings, the review highlights significant variability in study designs and treatment protocols, indicating a need for large randomized trials to accurately assess the efficacy and safety of SBRT for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of the Role of Stereotactic Radiotherapy for Bone Metastases. Spencer, KL., van der Velden, JM., Wong, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9627033/

Efficacy and safety of stereotactic body radiotherapy for painful ... This study shows that for painful bone metastases, patients with SBRT experienced better pain relief 3 months after radiation than patients with cRT.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814927

Stereotactic Body and Conventional Radiotherapy for ... In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38220068/

Clinical Outcomes After Stereotactic Body Radiation ... The estimated 1-year OS rate was 71.0% (95% CI, 51.7%-87.0%). SBRT results in excellent LC and palliation of symptoms with minimal related ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00239-7/fulltext

A Prospective Study Assessing the Efficacy and Toxicity of ... In this study, we report the results of our institutional phase II experience treating patients with 1 to 3 oligometastatic bone metastases with ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases The currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective therapy for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624000245

Clinical Outcomes After Stereotactic Body Radiation ... We performed a systematic review and meta-analysis to characterize local control (LC), overall survival (OS), pain response rates, and toxicity after SBRT.

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

Clinical Outcomes Among Patients Treated With ... There are limited data regarding outcomes after stereotactic body radiation therapy (SBRT) for femur metastases, which was an exclusion criteria.