108 Participants NeededMy employer runs this trial

Radiation Boost for Spine Cancer

(OPTIMAL Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an extra dose of radiation, known as a "Radiation Boost," can better control spinal tumors that have spread from other cancers and help relieve pain. The focus is on a technique called Spine SBRT, which delivers high doses of radiation directly to affected areas in the spine. Individuals with spinal metastases who plan to receive this specific type of radiation treatment may be suitable candidates. Participants should not have received prior radiation to the spine area under study and must be able to maintain a pain and medication diary. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had cytotoxic chemotherapy within 1 week before starting the trial treatment.

Is there any evidence suggesting that the Radiation Boost treatment is likely to be safe for humans?

Research has shown that increasing radiation doses for spine cancer can be safe and effective. Studies indicate that higher doses of radiation to spinal tumors are generally well-tolerated, even for difficult-to-treat cases. This treatment aims to control tumor growth and manage pain. Most patients tolerate the increased radiation without serious side effects. Specifically, some reports suggest that 35% of patients experience complete relief from spinal pain three months after treatment. Overall, the treatment has a strong record of safety and effectiveness.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for spine cancer, which often include conventional radiation therapy, chemotherapy, or surgery, the Radiation Boost offers a targeted approach. This treatment delivers an intensified dose of radiation directly to spinal metastases, potentially leading to more effective tumor control with fewer sessions. Researchers are excited because this method could maximize the impact on cancer cells while minimizing damage to surrounding healthy tissue, possibly improving patient outcomes and quality of life.

What evidence suggests that a radiation boost might be an effective treatment for spine cancer?

Research has shown that Spine SBRT, a precise form of radiation therapy, effectively treats cancer that has spread to the spine. Studies have found that this targeted radiation reduces pain and controls tumor growth. In this trial, participants will receive a radiation boost to their spinal metastases. A review of patients who received extra radiation to their spinal tumors found it safe and effective, especially for tumors typically harder to treat with radiation. Another study confirmed that increasing the radiation dose improved pain relief. Overall, evidence suggests that adding more radiation can enhance standard SBRT treatments for spinal cancer.24567

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cancer that has spread to their spine, confirmed by scans or biopsy. Participants must be well enough to handle treatment, able to keep a pain diary, and have not had prior radiation at the planned spinal site. They need to start treatment soon after planning and give consent.

Inclusion Criteria

I have been diagnosed with, or am strongly suspected to have, a solid tumor cancer.
I have spinal cancer that has spread near my spine and need SBRT treatment.
I am able to care for myself and do daily activities.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a radiation boost to their spinal metastases

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Radiation Boost

Trial Overview

The study tests if giving an extra dose ('boost') of focused radiation (SBRT) to painful spinal tumors improves long-term tumor control and pain relief compared to standard SBRT alone.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Radiation BoostExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Citations

Advances in Radiotherapy in the Treatment of Metastatic ...

In this context, SBRT introduction emerges as a valuable tool in managing spinal metastases, allowing a targeted and effective approach.

Safety and Efficacy of Dose-Escalated Radiotherapy with a ...

We reviewed 58 patients with 63 spinal metastatic sites that were treated with RT using a SSIB between 2012 and 2021. All patients received 30 ...

Efficacy and safety of SBRT for spine metastases

The currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective therapy for relieving pain with ...

Radiation to Treat Painful Spinal Metastases - NCI

Targeted Radiation Reduces Pain from Cancer Metastases in the Spine · A Painful Location · Boosting the Radiation Dose · Double the Pain Relief.

Phase 2 Trial of Stereotactic Body Radiation Therapy with ...

Overall, our results demonstrated that the delivery of dose-escalated SIB–SBRT to the GTV is a highly effective method for treating spinal metastases with ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36604100/

Safety and Efficacy of Dose-Escalated Radiation Therapy ...

Our data suggest that dose escalation to spine metastases using SSIB can be safe and efficacious for patients, especially those with radioresistant disease.

Safety and Efficacy of Dose-Escalated Radiation Therapy ...

Our data suggest that dose escalation to spine metastases using SSIB can be safe and efficacious for patients, especially those with radioresistant disease.