Radiation Therapy for Spinal Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Systemic radiotherapy

Disqualifiers: Spinal cord compression, Unstable spine, Multiple myeloma, others

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

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.

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 participate if you have received chemotherapy within the last 30 days.

What data supports the effectiveness of the treatment for spinal cancer?

Research shows that stereotactic body radiation therapy (SBRT) is highly effective for treating spinal metastases, improving pain relief and local tumor control compared to traditional methods. Studies report a high local control rate of 90% and low risk of side effects, making it a safe and effective option for spinal cancer treatment. ^{1 2 3 4 5}

Is radiation therapy for spinal cancer safe for humans?

Radiation therapy for spinal cancer, including techniques like stereotactic body radiation therapy (SBRT) and stereotactic radiosurgery (SRS), has been shown to be safe in humans. Studies report high local control rates and low risks of serious side effects, such as radiation myelopathy (damage to the spinal cord), with no significant adverse events observed in treated patients. ^{1 3 6 7 8}

How is the treatment CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) different from other treatments for spinal cancer?

The CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) is unique because it delivers precise, high-dose radiation directly to the spine with high accuracy, minimizing damage to surrounding tissues. This approach allows for effective treatment of spinal metastases with fewer sessions compared to traditional radiation therapy, offering improved local control and reduced risk of side effects. ^{1 2 3 8 9}

Research Team

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with metastatic spine tumors from various cancers, including lung and breast cancer. Participants must have a Karnofsky performance status of at least 40, can have had one prior spine radiotherapy, and up to two spinal metastatic sites. Exclusions include recent chemotherapy, inability to undergo MRI or lie flat for treatment duration, previous maximum radiation dose received, unstable spine needing surgery, pacemaker presence or immediate need for surgical decompression.

Inclusion Criteria

My MRI shows cancer spread to my spine or near it within the last 4 weeks.

I have had only one spine radiotherapy session in the affected area.

I have up to 2 cancer spots in my spine needing radiation.

Exclusion Criteria

I have not had chemotherapy in the last 30 days.

I need urgent surgery or radiation due to spinal cord pressure shown on scans.

Delaying my radiation treatment could harm my brain function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person)

Pretreatment Feasibility Study

A pretreatment feasibility study to determine precision, accuracy, and reproducibility of target volume positioning

1 week

1 visit (in-person)

Treatment

Radiation therapy using CT-on-Rails or Trilogy procedure, with 3 treatments over 2 weeks

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits scheduled at various intervals

24 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)

Trial Overview The study evaluates the safety and effectiveness of stereotactic spine radiotherapy (SSRS) using CT-on-rails in treating spinal tumors. It will assess the precision of this technology and document any side effects experienced by participants during treatment.

Participant Groups

Group I: Radiation Therapy Experimental Treatment 1 Intervention

Radiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

This study involves 120 patients with spinal bone metastases receiving stereotactic body radiation therapy (SBRT) with different fractionation schedules to evaluate local tumor control and safety.

The trial aims to compare the effectiveness of SBRT with and without simultaneous integrated boost (SIB) in improving tumor targeting and patient outcomes, including pain relief and quality of life, over a follow-up period of three to six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. Sprave, T., Welte, SE., Bruckner, T., et al.[2023]

Stereotactic body radiotherapy (SBRT) using a regimen of 24 Gy in 2 fractions has shown high efficacy for treating spinal metastases, with 1-year local control rates between 83-93.9% and low rates of treatment-related complications, such as plexopathy and radiculopathy under 5%.

This SBRT regimen is not only effective for initial treatment but also feasible for reirradiation of previously treated spine metastases, maintaining local control rates of 72-86%, making it a strong option for patients with challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. Nguyen, EK., Ruschin, M., Zhang, B., et al.[2023]

Stereotactic body radiation therapy (SBRT) is an effective and safe treatment for spinal bone metastasis, enhancing local control and improving patients' quality of life.

Key factors influencing treatment decisions include life expectancy, fracture risk, localization and size of metastases, and nerve compression, highlighting the need for further studies to identify which patients will benefit most from SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. Cihan, YB.[2019]

The phase 2 study of spine radiosurgery (SRS) for treating localized spine metastases demonstrated high feasibility and safety, with 95% accuracy in targeting and 100% compliance in target coverage and spinal cord dose constraints among 44 eligible patients.

No severe acute treatment-related toxicities (grade 4-5) were reported, indicating that SRS is a safe option for patients with significant pain from spine metastases, paving the way for a phase 3 trial to further evaluate its effectiveness compared to traditional external beam radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Ryu, S., Pugh, SL., Gerszten, PC., et al.[2022]

In a study of 20 patients with spine metastases treated with stereotactic body radiation therapy-simultaneous integrated boost, 100% of patients experienced pain remission, with 85% achieving complete remission, indicating high efficacy in pain management.

The treatment demonstrated excellent local control with an 86.36% rate of local progression-free survival over a median follow-up of 35 months, and it was found to be safe, with no reported adverse radiation events or vertebral compression fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost in Patients With Spinal Metastases. Pontoriero, A., Iatì, G., Cacciola, A., et al.[2020]

In a study of 132 patients receiving spine stereotactic radiosurgery (SSRS), there were no observed cases of radiation myelopathy (RM) after treatment, even with spinal cord doses exceeding 12 Gy, suggesting a very low risk of RM.

The 1-year local control rate for spine metastases was high at 94%, indicating that SSRS is an effective treatment option while allowing for a safe increase in radiation dose to the spinal cord without significant risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low risk of radiation myelopathy with relaxed spinal cord dose constraints in de novo, single fraction spine stereotactic radiosurgery. Diao, K., Song, J., Thall, PF., et al.[2023]

Spinal metastases are common and can severely affect quality of life due to pain and mobility issues, making effective treatment essential.

Stereotactic radiosurgery (SRS) offers a precise method for delivering radiation to spinal metastases, potentially improving local control and outcomes for patients, as demonstrated in a case study using advanced tomotherapy technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal metastases: case report and review of treatment options. Chawla, S., Abu-Aita, R., Philip, A., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. [2023]

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

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]

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

Stereotactic body radiosurgery for spinal metastatic disease: an evidence-based review. [2023]

4. Thailand pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]

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

The impact of radiosensitivity on clinical outcomes of spinal metastases treated with stereotactic body radiotherapy. [2023]

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

RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. [2022]

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

Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost in Patients With Spinal Metastases. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

Low risk of radiation myelopathy with relaxed spinal cord dose constraints in de novo, single fraction spine stereotactic radiosurgery. [2023]

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

Stereotactic radiosurgery for spinal metastases: case report and review of treatment options. [2016]