Vertebroplasty + SBRT for Spinal Cancer Pain Management
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byVéronique Freire, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Disqualifiers: Pregnancy, Myeloma, Lymphoma, Plasmacytoma, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of this treatment for spinal cancer pain management?
Research shows that stereotactic body radiation therapy (SBRT) is highly effective for treating spinal metastases, providing better pain relief and local control compared to conventional radiation therapy. Additionally, combining SBRT with vertebroplasty can help manage pain and prevent vertebral fractures in patients with spine metastases.
12345Is the combination of vertebroplasty and SBRT safe for managing spinal cancer pain?
Stereotactic body radiotherapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), has been shown to be safe for treating spinal metastases, with studies indicating acceptable levels of toxicity. This suggests that SBRT is generally safe for use in humans, although specific safety data for the combination with vertebroplasty is not provided in the available research.
16789How is the treatment Vertebroplasty + SBRT for spinal cancer pain management different from other treatments?
This treatment combines vertebroplasty, a procedure to stabilize spinal bones, with SBRT, a precise form of radiation therapy that delivers high doses to spinal tumors, offering potentially greater and longer-lasting pain relief compared to traditional radiation methods.
123510Eligibility Criteria
This trial is for adults with cancer-related spinal pain, unstable spine lesions, and confirmed spinal metastases from T5 to L5. They must be able to handle radiation therapy, have a decent performance status (Karnofsky >60), and can't have more than 3 consecutive affected spine levels. Excluded are those with infections, MRI contraindications, prior treatments at the same site, large lesions or coagulation issues, severe neurological symptoms, certain cancer types like myeloma or lymphoma, pregnant/breastfeeding women or very short life expectancy.Inclusion Criteria
My cancer diagnosis was confirmed through tissue examination.
Less than 3 consecutive levels reached
I can care for myself but may not be able to do active work.
+5 more
Exclusion Criteria
Pregnancy or breastfeeding
Estimated survival of less than 6 months
I cannot or will not undergo SBRT treatment or vertebroplasty.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) or SBRT alone
1 month
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Visits at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months
Participant Groups
The study tests if adding vertebroplasty (a procedure that stabilizes the spine) before standard stereotactic body radiation therapy (SBRT) provides better early pain relief for patients with painful spinal bone metastases compared to SBRT alone.
2Treatment groups
Experimental Treatment
Group I: V-SBRTExperimental Treatment1 Intervention
Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)
Group II: SBRTExperimental Treatment1 Intervention
SBRT is the actual standard of care.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CHUMMontréal, Canada
Véronique FreireMontréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]Stereotactic body radiotherapy (SBRT) has proven to be a highly effective treatment for selected patients with spinal metastases. Randomized evidence shows improvements in complete pain response rates and local control with lower retreatment rates favoring SBRT, compared to conventional external beam radiotherapy (cEBRT). While there are several reported dose-fractionation schemes for spine SBRT, 24 Gy in 2 fractions has emerged with Level 1 evidence providing an excellent balance between minimizing treatment toxicity while respecting patient convenience and financial strain.
A Phase 2 Clinical Trial of SABR Followed by Immediate Vertebroplasty for Spine Metastases. [2019]To determine the pain response and prevention of vertebral compression fractures (VCFs) after single-fraction stereotactic ablative radiation therapy (SABR) in conjunction with immediate vertebroplasty for spine metastases.
[Stereotactic body radiation therapy (SBRT) for pain management in spine bone metastases]. [2020]Treatment of spine bone metastases with stereotactic radio-therapy (SBRT) may produce greater pain relief than palliative radiotherapy.
Mature Local Control and Reirradiation Rates Comparing Spine Stereotactic Body Radiation Therapy With Conventional Palliative External Beam Radiation Therapy. [2022]Stereotactic body radiation therapy (SBRT) improves complete pain response for painful spinal metastases compared with conventional external beam radiation therapy (cEBRT). We report mature local control and reirradiation rates in a large cohort of patients treated with SBRT versus cEBRT enrolled previously in the Canadian Clinical Trials Group Symptom Control 24 phase 2/3 trial.
Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]Stereotactic body radiotherapy (SBRT) is used to deliver ablative dose of radiation to spinal metastases.
Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. [2022]The role of stereotactic ablative radiotherapy (SABR) in patients with hepatocellular carcinoma (HCC) who are refractory to or unsuitable for transarterial chemoembolization remains unclear. We examined the efficacy and safety of Cyberknife SABR and its effect on survival in this group of HCC patients.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Stereotactic ablative radiation therapy for spinal metastases: experience at a single Brazilian institution. [2023]This study aims to assess the clinical outcomes of patients with spine metastases who underwent stereotactic ablative radiation therapy (SABR) as part of their treatment. SABR has arisen as a contemporary treatment option for spinal metastasis patients with good prognoses.
CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.
Cost-effectiveness analysis of single fraction of stereotactic body radiation therapy compared with single fraction of external beam radiation therapy for palliation of vertebral bone metastases. [2022]Stereotactic body radiation therapy (SBRT) has been proposed for the palliation of painful vertebral bone metastases because higher radiation doses may result in superior and more durable pain control. A phase III clinical trial (Radiation Therapy Oncology Group 0631) comparing single fraction SBRT with single fraction external beam radiation therapy (EBRT) in palliative treatment of painful vertebral bone metastases is now ongoing. We performed a cost-effectiveness analysis to compare these strategies.