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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy to determine its safety and effectiveness for treating spine tumors that have spread from other parts of the body. Researchers aim to evaluate how well this precise radiation treatment, called stereotactic spine radiotherapy, works and identify any side effects. Suitable participants have spine tumors from cancers such as lung, breast, or prostate cancer and have received no more than one previous radiation treatment to the affected area. As a Phase 1, Phase 2 trial, this study focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

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 prior data suggests that stereotactic spine radiotherapy is safe for treating metastatic spine tumors?

Research has shown that stereotactic spine radiotherapy, such as the CT-on-rails or Trilogy system, is generally safe for treating spinal tumors. Studies have found that patients tolerate this focused radiation therapy well. It precisely targets tumors, reducing harm to nearby healthy tissue.

In past studies, many patients experienced few serious side effects. Common mild side effects included temporary tiredness and localized pain at the treatment site, while severe side effects were rare. This precise treatment is already used effectively for spinal metastatic disease, indicating its general safety for this type of cancer.

While these findings are encouraging, joining a clinical trial can involve some unknowns. Discuss any concerns with your healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the CT-On-Rails and Trilogy Stereotactic Spine Radiotherapy System (SSRS) for spinal cancer because these treatments offer a highly targeted form of radiation therapy. Unlike traditional radiation treatments that can affect a larger area, these systems deliver precise doses of radiation directly to the tumor, minimizing damage to surrounding healthy tissue. This precision could mean fewer side effects and improved outcomes for patients. Additionally, the ability to deliver a higher radiation dose in fewer sessions offers the possibility of more convenient treatment schedules, potentially leading to quicker symptom relief and better quality of life.

What evidence suggests that stereotactic spine radiotherapy is effective for spinal cancer?

Research has shown that stereotactic spine radiotherapy (SSRS) is a safe and effective treatment for cancer that has spread to the spine. This trial will employ the CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) to precisely target tumors, potentially reducing pain and maintaining spine stability. One study found that delivering larger doses of radiation in fewer sessions, known as hypofractionated SSRS, provided significant benefits for patients. Researchers are also investigating the use of CT-on-rails technology to enhance treatment accuracy. Overall, early results suggest that SSRS is a promising method for managing spinal tumors. ^{1 2 3 4 5}

Who Is on the Research Team?

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00508443

Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3605896/

A prospective analysis of the clinical effects of stereotactic ... This study investigated the clinical benefit of using hypofractionated stereotactic body radiotherapy (SBRT) to manage spinal metastases in patients with cancer

3. withpower.com withpower.com/trial/phase-2-spinal-neoplasms-9-2002-5d73f

Radiation Therapy for Spinal Cancer · Info for Participants Trial Overview The study evaluates the safety and effectiveness of stereotactic spine radiotherapy (SSRS) using CT-on-rails in treating spinal tumors. It will ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875021018143

Clinical Trials in Spinal Tumors: A Two-Decade Review The purpose of the present study was to characterize the trends in clinical trials for primary and metastatic tumor treatment during the past 2 decades.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3263656/

Stereotactic Body Radiosurgery for Spinal Metastatic Disease Stereotactic body radiosurgery is an established treatment modality for patients with spinal metastatic disease that is both safe and highly effective.