SBRT for Oligometastasis

LH
Overseen ByLauren Henke, MD, MSCI
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a faster method to plan and deliver Stereotactic Body Radiation Therapy (SBRT) for individuals with cancer that has spread to up to five spots, known as oligometastasis. The goal is to determine if using existing diagnostic scans, instead of scheduling new ones, can safely and effectively accelerate treatment. This approach could enable patients to begin treatment sooner and potentially experience quicker symptom relief. Suitable candidates have been diagnosed with cancer that has spread to a few specific areas and have been recommended for SBRT by their doctor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

You will need to stop any active cancer treatments, like chemotherapy or biological treatments, at least one week before starting radiation therapy and can restart them no sooner than one week after finishing radiation therapy. However, you can continue taking endocrine therapies (hormone treatments) during the radiation treatment.

What prior data suggests that this simulation-free workflow is safe for SBRT?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating cancers that have spread to a few areas, known as oligometastases. A large study from Brazil found that SBRT is both safe and effective for these types of cancers. Another review demonstrated that SBRT helped control cancer in the lungs for patients with oligometastatic disease, indicating it works well in the early stages.

An analysis of several studies examined patient outcomes over time. It found that many people were doing well a year after treatment, with survival rates between 53% and 88%. Two years later, more than 60% of patients were still doing well, although this dropped to about 40% after three years.

These studies suggest that SBRT is well-tolerated, meaning most people do not experience serious side effects. The CT-simulation-free planning method aims to speed up the process, so treatment can start sooner. While this study is new, the basic SBRT method has shown promise in previous research.12345

Why are researchers excited about this trial?

Researchers are excited about the new approach using SBRT, or Stereotactic Body Radiation Therapy, for treating oligometastasis because it offers a unique, simulation-free treatment delivery. Unlike traditional radiation therapies that often require extensive planning and multiple sessions, this technique simplifies the process and potentially reduces treatment time. Additionally, SBRT precisely targets tumors with high doses of radiation while sparing surrounding healthy tissue, which could lead to fewer side effects. This precision and efficiency make it a promising alternative to conventional methods, such as whole-body radiation or surgery, that can be more invasive or time-consuming.

What evidence suggests that CT-sim-free planning is effective for SBRT in treating oligometastases?

Research has shown that SBRT, a type of precise radiation therapy, effectively treats oligometastatic cancer, where cancer spreads to only a few areas. For cancer that has spread to the lungs, SBRT has successfully stopped cancer growth in the treated spots. Studies also report good outcomes for patients with this type of cancer when treated with SBRT. In this trial, participants will receive SBRT using a simulation-free workflow, a planning method that doesn't require a CT simulation. This approach has proven effective for other advanced cancers, potentially speeding up treatment and reducing delays. Overall, SBRT with this planning method appears promising for treating cancer that has spread to a few areas effectively and quickly.26789

Who Is on the Research Team?

LH

Lauren Henke, MD, MSCI

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals

Are You a Good Fit for This Trial?

This trial is for people with oligometastatic cancer, where the disease has spread to up to five areas. They should be recommended for SBRT by their doctor and have had a recent CT or other radiology scan that can be used for planning treatment without additional simulations.

Inclusion Criteria

Estimated life expectancy of at least 3 months
Participants must have a diagnostic CT, MRI, or PET/CT of the site(s) intended for treatment, with or without contrast, acquired no more than 30 days prior to study consent
My cancer is confirmed and has spread to 5 or fewer places.
See 5 more

Exclusion Criteria

Pregnant or breastfeeding women are excluded from this study
Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by the treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test
I have had radiotherapy in the same area where the new treatment is planned.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive simulation-free SBRT using online adaptive radiotherapy for oligometastases

Up to 2 weeks
Multiple visits for radiation delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SBRT
  • Simulation-free workflow
Trial Overview The study tests if using existing diagnostic scans for immediate SBRT planning—without extra CT simulations—is safe and effective in treating oligometastases, potentially speeding up treatment and symptom relief.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Simulation-free treatment delivery of SBRTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

Trial of Oligometastasis SBRT With Immediate, Simulation ...CT-sim-free radiation therapy planning has been shown to be effective in treating cancers that are causing pain in people with more advanced or widespread ...
stereotactic body radiotherapy (SBRT) for oligometastatic ...Preliminary data for lung metastasis in oligometastatic patients support SBRT as a viable method of achieving high rates of early local control.
A Prospective Study Assessing the Efficacy and Toxicity of ...Our results contribute to the growing body of literature regarding disease outcomes following SBRT treatment for oligometastatic disease.
Results of a Single-Arm Phase 2 Clinical Trial: Online ...This study reports on the clinical outcomes of the single-arm phase-2 STEAL trial investigating online adaptive stereotactic body radiation therapy (SBRT) for ...
May 20251754 Dose-intensified stereotactic body radiation therapy for vertebral oligometastases: results from a prospective clinical trial. Matthias ...
Evaluation of the Safety and Efficacy of Stereotactic Body ...This study represents the largest cohort demonstrating the safety and efficacy of SBRT for the treatment of oligometastatic disease in Brazil.
Feasibility, safety and outcomes of stereotactic ...A meta-analysis of unguided-SBRT in mediastinal and hilar oligometastases found OS rates of 53–88 % at 12 months, >60 % at 24 months and ∼ 40 % ...
Evaluation of the Safety and Efficacy of Stereotactic Body ...This study represents the largest cohort demonstrating the safety and efficacy of SBRT for the treatment of oligometastatic disease in Brazil. Ongoing analyses ...
Efficacy and Safety of Metastatic Directed Treatment ...Here, we report a meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of adding stereotactic radiation to metastases ...
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