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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other 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 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 data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for bone cancer?

Research suggests that SBRT, a precise radiation therapy, can effectively manage bone metastases by delivering high doses of radiation to the target area while sparing nearby healthy tissues. It has shown potential in improving pain and local control in patients with bone metastases compared to conventional radiotherapy. ^{1 2 3 4 5}

Is SBRT generally safe for humans?

SBRT has been studied for various conditions, including bone metastases and prostate cancer, and is generally considered safe, though there are risks of complications like vertebral fractures and other toxicities. ^{6 7 8 9 10}

How is SBRT treatment different from other treatments for bone cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers a high dose of radiation precisely to the target area in one or a few sessions, minimizing damage to surrounding healthy tissue. This is different from conventional radiation therapy, which typically involves multiple lower-dose treatments and may affect more of the surrounding area. ^{5 7 9 11 12}

Research Team

Tracy Balboni, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Ten-year experience of bone SBRT in breast cancer: analysis of predictive factors of effectiveness. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

[Quality Assurance of Bone SBRT]. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Could conventionally fractionated radiation therapy coupled with stereotactic body radiation therapy improve local control in bone oligometastases? [2023]

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

Systematic Review of the Role of Stereotactic Radiotherapy for Bone Metastases. [2021]

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

Stereotactic body radiotherapy in the management of painful bone metastases. [2008]

6. England pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]

7. 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]

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

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Re-irradiation for painful bone metastases using stereotactic body radiotherapy. [2019]

10. Germany 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. [2022]

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

Comparison of Clinical Outcomes Stratified by Target Delineation for Patients Undergoing Stereotactic Body Radiotherapy for Spinal Metastases. [2020]

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

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]