Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (CURB-Melanoma) - a Phase 2 Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This open-label, prospective, single-arm Phase II trial explores whether adding stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy to oligoprogressive lesions can help delay disease progression in patients with metastatic melanoma. Participants may have up to ten extracranial oligoprogressive sites, with no upper limit on the total number of metastatic lesions. The study aims to assess whether targeting these progressing sites with focused radiotherapy can extend progression-free survival in this patient population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• ECOG 0-2

• Willing and able to provide informed consent

• Metastatic melanoma detected on imaging and clinically confirmed.

• Treated with first line immunotherapy or BRAF inhibitors.

• No upper limit to the number of total metastatic sites, but a maximum of ten progressive metastatic sites, inclusive of primary disease and metastatic lesions, all of which must be extra cranial.

• Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.

• All sites of oligoprogression that can be safely treated with SBRT or hypofractionated radiotherapy.

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Jillian C Tsai, MD
jillian.tsai@uhn.ca
416-946-4501
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2028-07-24
Participants
Target number of participants: 52
Treatments
Experimental: Single Arm
This is a single-arm trial, meaning all participants will receive the same treatment. There is no control or comparison group. All eligible patients will continue their existing first-line systemic therapy and receive additional radiation treatment-either stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy-directed at oligoprogressive lesions. The outcomes will be measured and analyzed based on this single group.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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