Actively Recruiting
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (CURB-Melanoma) - a Phase 2 Clinical Trial
Led by University Health Network, Toronto · Updated on 2026-03-05
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy to treat oligoprogressive lesions in patients with metastatic melanoma. This open-label, single-arm Phase II trial focuses on patients who have up to ten extracranial progressing sites while continuing their first-line systemic therapy. The goal is to see if targeting these progressing lesions can delay overall disease progression and extend the benefit of ongoing treatment. All participants will continue their current systemic therapy and receive SBRT or hypofractionated radiotherapy directed at all oligoprogressive lesions. This study does not include a comparison group; instead, all patients receive the same treatment. Radiation will be delivered according to institutional standards, and treatment focuses on safely targeting the limited sites of disease progression. Participants will be monitored through imaging studies to assess disease progression, and blood samples will be collected at baseline, after radiation, and at progression for further analysis. The study will track progression-free survival as the primary outcome over 24 months, along with overall survival, time on current therapy, toxicity, quality of life, and participant-reported adverse events. The full participation period spans up to 24 months with regular assessments.
CONDITIONS
Brief Title
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- ECOG performance status 0-2
- Willing and able to provide informed consent
- Metastatic melanoma confirmed by imaging and clinical diagnosis
- Receiving first-line immunotherapy or BRAF inhibitors
- Up to ten progressive metastatic sites, all extracranial
- Prior radiation therapy near or overlapping oligoprogressive sites allowed
- All oligoprogressive sites can be safely treated with SBRT or hypofractionated radiotherapy
You will not qualify if you...
- More than 10 extracranial sites of progressive disease
- Pregnancy
- Leptomeningeal disease
- Serious medical conditions preventing radiotherapy such as ataxia-telangiectasia or scleroderma
- Prior radiotherapy near lesions exceeding organ tolerance, preventing SBRT or hypofractionated radiotherapy
- Psychological, sociological, or geographical issues interfering with study compliance
- Any condition making the patient inappropriate for study entry according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants continue their current systemic therapy and receive stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy to all oligoprogressive lesions.
Radiotherapy delivered per institutional standard with visits as needed for treatment and assessments
Duration - Up to 24 months
Participants are monitored with imaging and blood samples to assess disease progression, overall survival, toxicity, and quality of life after treatment.
Imaging and blood sample collections at baseline, after radiation, and at disease progression
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada
Actively Recruiting
Research Team
J
Jillian C Tsai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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