Palliative Radiation Therapy for Bone Metastases

(SIM-FREE RT Trial)

Overseen By Shane Lloyd, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Spinal cord compression, cognitive conditions, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for individuals with cancer that has spread to their bones, causing pain or instability. The aim is to determine if a single, quick radiation treatment without prior simulations can effectively relieve symptoms in just one visit. It targets adults diagnosed with cancer who have one or two painful bone spots suitable for this approach. Participants must have a CT scan showing the bone area to be treated and must understand and agree to the trial's rules. As an unphased trial, this study offers a unique opportunity for potential symptom relief in a single visit.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that participants taking certain prohibited medications cannot join. It's best to discuss your current medications with the study team to see if they are allowed.

What prior data suggests that this radiation therapy is safe for patients with bone metastases?

Research has shown that simulation-free, single-fraction palliative radiation therapy is generally easy for patients to handle. In past studies, this treatment proved safe with few side effects. For example, one study found it relieved symptoms effectively without causing major problems. This radiation therapy is designed to be quick and convenient, focusing on making the treatment as comfortable and simple as possible for patients. While more research is needed, early results suggest it is a safe way to manage pain from cancer that has spread to the bones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about simulation-free, single-fraction palliative radiation therapy for bone metastases because it offers a more streamlined and potentially quicker approach compared to traditional radiation treatments. Unlike standard methods, which often involve multiple sessions and complex setup procedures, this treatment simplifies the process by eliminating the simulation step. This could lead to faster relief of symptoms for patients, less time spent in treatment, and reduced healthcare costs. By focusing on efficiency and patient convenience, this approach has the potential to significantly improve the quality of life for individuals dealing with painful bone metastases.

What evidence suggests that simulation-free, single-fraction palliative radiation therapy is effective for bone metastases?

Research has shown that a quick, one-time radiation treatment, administered without the usual pre-treatment planning, can effectively ease symptoms for patients with cancer that has spread to the bones. Studies have found that this method provides relief with fewer side effects, allowing patients to feel better without many negative reactions. One study noted that skipping the planning step speeds up the treatment without reducing its effectiveness. This approach holds promise for reducing pain and improving the quality of life for these patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cancer that has spread to the bones, causing pain or instability. They must be able to consent, have a recent CT scan showing the affected area, and an ECOG Performance Status of ≤2. People can't join if they have conditions affecting study compliance or safety, cognitive issues preventing informed consent, are taking certain medications, or have spinal cord compression from bone metastases.

Inclusion Criteria

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

I am 18 years old or older.

I have cancer with 1-2 painful bone metastases.

Exclusion Criteria

Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures

Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand information, give informed consent, comply with the study protocol, or complete the study

Participants taking prohibited medications as described in Section 6.7.1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Radiation

Participants receive simulation-free, single-fraction palliative radiation therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Simulation-Free, Single-Fraction Palliative Radiation Therapy

Trial Overview The study tests a one-time radiation therapy treatment for bone metastases that doesn't require simulation and aims to reduce visits. It's designed to see if patients can receive effective care in just one appointment.

How Is the Trial Designed?

Group I: Simulation-free, single-fraction palliative radiation therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512154/

Simulation-free palliative radiotherapy using diagnostic CT ... Clinical outcome data showed low toxicity and effective symptom relief. Keywords: Cancer, Palliative, Radiotherapy, CT, Workflows. Abstract.

2. trial.medpath.com trial.medpath.com/clinical-trial/b73137650eaa3a61/nct07202273-simulation-free-single-fraction-palliative-radiation-bone-metastases

Simulation-Free, Single-Fraction Palliative Radiation Therapy ... The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)00076-2/fulltext

Early outcomes in the FAST-METS study The present study describes the implementation of this simulation CT-free adaptive workflow using Ethos for patients referred for palliative RT.

4. redjournal.org redjournal.org/article/S0360-3016(24)01300-2/fulltext

Simulation-Free Single-Fraction Stereotactic Body ... The aim of this study is to assess the feasibility and efficiency of a simulation-free single-fraction SBRT for non-spine bone metastases.

5. sciencedirect.com sciencedirect.com/science/article/pii/S245210942200197X

Simulation-Free Radiation Therapy: An Emerging Form of ... Palliative treatment of bone,, brain,, and lung metastases,, among others, is common and has been demonstrated to reduce symptoms in a variety of diseases.

6. redjournal.org redjournal.org/article/S0360-3016(24)03413-8/fulltext

A Propensity Score-Matched Analysis of 1000 Consecutive ... The feasibility of simulation-free radiation therapy (SFRT) has been demonstrated but information regarding its routine care impact and ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jmrs.70011

Simulation‐Free Palliative Radiation Therapy ... Palliative radiation therapy (RT) is a proven, cost-effective treatment that helps alleviate symptoms from bony and soft tissue metastases, such ...