52 Participants Needed

Radiotherapy for Metastatic Melanoma

(CURB-Melanoma Trial)

JC
Overseen ByJillian C Tsai, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Must be taking: Immunotherapy, BRAF inhibitors
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 special type of radiation treatment called SBRT (Stereotactic Body Radiation Therapy) for individuals with metastatic melanoma, where the cancer has spread to other parts of the body. The goal is to determine if adding this focused radiation to areas of active cancer growth can prevent further progression. Participants will continue their current cancer medication while receiving the radiation treatment. The trial seeks individuals with up to ten active cancer spots outside the brain who are already on first-line treatments like immunotherapy or BRAF inhibitors.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance current therapies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these radiotherapy techniques are safe for treating metastatic melanoma?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is generally easy for patients to handle. Many studies have found that most people experience only mild side effects. In one study, 49% of patients reported some side effects, but these were mostly mild. Importantly, no serious side effects that would limit treatment emerged. Another study highlighted that SBRT carries a low risk of side effects when treating melanoma patients with cancer spread outside the brain. This suggests that SBRT is a safe option for many people.12345

Why are researchers excited about this trial?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers highly focused radiation to metastatic melanoma lesions, minimizing damage to surrounding healthy tissue. Unlike traditional treatments like chemotherapy, which affects the entire body, SBRT targets specific areas, potentially reducing side effects and improving quality of life. Researchers are excited about SBRT's precision and its ability to be combined with existing systemic therapies, offering a promising approach for patients with limited disease progression.

What evidence suggests that this radiotherapy is effective for metastatic melanoma?

Research has shown that stereotactic body radiotherapy (SBRT) effectively treats melanoma when the cancer spreads to a few areas outside the brain. Studies have found that SBRT manages these cases with generally low side effects. In this trial, all participants will receive SBRT alongside their existing first-line systemic therapy. One study found that combining SBRT with other treatments improved outcomes for advanced melanoma. Most patients experienced few side effects, and those that did were mostly mild. This suggests SBRT could help slow the spread of metastasized melanoma.36789

Are You a Good Fit for This Trial?

This trial is for patients with metastatic melanoma who are experiencing limited progression in up to ten extracranial sites, regardless of the total number of metastases. Participants should be suitable for radiotherapy and have measurable disease.

Inclusion Criteria

I have had radiation therapy near my current cancer sites and can join the study.
I have been treated with first line immunotherapy or BRAF inhibitors.
I have 10 or fewer growing cancer spots outside the brain.
See 5 more

Exclusion Criteria

My cancer has spread to more than 10 places outside of my brain.
My cancer has spread to the lining of my brain and spinal cord.
I've had radiotherapy near my cancer that now prevents more due to safety limits.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy to oligoprogressive lesions while continuing systemic therapy

Up to 24 months
Regular visits for radiotherapy sessions and systemic therapy monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Imaging and blood sample collection at baseline, after radiation, and at disease progression

What Are the Treatments Tested in This Trial?

Interventions

  • Stereotactic Body Radiation Therapy (SBRT)
Trial Overview The study tests if adding focused radiotherapy (SBRT or hypofractionated) to a few progressing cancer spots can help control metastatic melanoma better and delay overall disease progression.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Stereotactic body radiotherapy as a viable treatment on ...SBRT demonstrated efficacy in managing melanoma patients with extracranial oligometastases and showed an overall low toxicity profile.
Clinical Outcomes and Toxicity using Stereotactic Body ...In general SBRT was well-tolerated, with 18 patients (49%) reporting toxicity, the majority of which was Grade 1 or 2. Two patients (5%) ...
The Role of Stereotactic Radiotherapy in the Management ...In our study we found that systemic therapy combined with stereotactic radiation therapy may improve the efficacy of the treatment in advanced ...
MSB0010445 and Stereotactic Body Radiation Therapy in ...This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, ...
A Prospective Study Assessing the Efficacy and Toxicity of ...Most patients (75.0%; 72/96) had a single metastatic bone site treated with SBRT, and 25.0% (24/96) had 2 to 3 lesions treated (Table 1).
Clinical outcomes of multisite moderate to high dose ...We analyzed 34 patients with 79 lesions, with a median follow‐up of 17.4 months. Sixty‐eight percent of patients received systemic therapy after the first HDRT.
Clinical Outcomes Among Patients Treated With ...With median follow-up 19.4 months, 1- and 2-year rates of local control were 94% and 89%, locoregional control was 83% and 67%, progression-free ...
Stereotactic body radiotherapy as a viable treatment on ...SBRT demonstrated efficacy in managing melanoma patients with extracranial oligometastases and showed an overall low toxicity profile.
Evaluation of Safety of Stereotactic Body Radiotherapy for ...Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...
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