Stereotactic Body Radiation Therapy for Spine Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to delivering radiation therapy for individuals with metastatic spinal cancer who have undergone spine surgery. It aims to determine if administering radiation during the same hospital stay as the surgery reduces complications and improves cancer control. The trial will assess the safety of this approach and its effectiveness in managing the cancer. Individuals who have recently had surgery to treat spinal cancer and are cleared for radiation therapy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer treatment research.
What prior data suggests that Stereotactic Body Radiation Therapy (SBRT) is safe for postoperative spine metastases?
Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating cancer that has spread to the spine. Studies have found that SBRT successfully controls spinal cancer in 90% of patients after one year. Most patients experience only mild side effects. Fewer than 2% of patients require surgery for issues such as vertebral compression fractures, which occur in about 10% of cases. Overall, SBRT is well-tolerated and serves as a good option for many patients.12345
Why are researchers excited about this trial?
Researchers are excited about using Stereotactic Body Radiation Therapy (SBRT) for treating spine metastases because it offers precise targeting of cancerous areas, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapy, which can take weeks, SBRT delivers high doses of radiation in just one to five sessions. This could potentially provide faster relief and better outcomes for patients who have undergone spinal decompression or debulking surgery. Additionally, the use of advanced imaging techniques like CT and MRI ensures high accuracy in targeting the tumor, boosting the treatment's effectiveness and safety.
What evidence suggests that this trial's treatments could be effective for spine metastases?
Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats cancer that has spread to the spine. In this trial, participants will receive SBRT after either decompression or debulking surgery. Studies indicate that SBRT controls the tumor in 80% to 96% of patients after one year. Most patients also experience pain relief, although the quality of the data varies. Safety information indicates a small risk of side effects, such as fractures in the spine bones, occurring in about 10% of patients. Overall, SBRT offers promising tumor control and pain management for spinal cancer.23467
Who Is on the Research Team?
Steve Braunstein, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for patients who have had surgery for spine metastases. It's designed to see if giving radiation therapy right after surgery, within the same hospital stay, can help without causing wound issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo decompression or debulking surgery for spinal metastases
Radiation Therapy
Participants receive short interval postoperative Stereotactic Body Radiation Therapy (SBRT) within 3-14 days after surgery
Follow-up
Participants are monitored for safety, wound complications, and local tumor control
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Body Radiation Therapy (SBRT)
Trial Overview
The study tests early postoperative Stereotactic Body Radiation Therapy (SBRT) following surgical intervention for spine metastases. It includes MRI and CT simulation to guide treatment and questionnaires to assess outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
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 ...
Oncological outcomes and safety after spinal reirradiation with ...
These data suggest that reirradiation of progressive or recurrent spinal metastases using SBRT is associated with excellent local control and ...
Efficacy and safety of SBRT for spine metastases
Spine SBRT is associated with high rates of local control. •. ∼10 % get post-SBRT vertebral compression fractures with < 2 % needing surgery.
Long-Term Outcomes After Reirradiation With Spine ...
At 1 year, overall survival was 61% with a cumulative incidence of local failure at 12% and vertebral compression fracture at 9% considering ...
Stereotactic Body Radiation Therapy (SBRT) for Spinal...
Following SBRT, 1- and 2-year OS rates were 53.4% (95% confidence interval [CI]: 48.3%-58.1%) and 33.6% (95% CI: 28.7%-38.6%), respectively. Following initial ...
Oncological outcomes and safety after spinal reirradiation ...
Conclusions: SBRT reirradiation for progressive or recurrent spinal metastases appears to be a safe and effective treatment option, offering ...
Oncologic and Functional Outcomes After Stereotactic ...
Five of 13 patients (38.4%) with initial Bilsky grade 3 improved to grade 1 to 2. Pain response at 3 and 6 months post-SBRT was complete in 45.4 ...
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