Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma (NCT07112170) | Clinical Trial Compass
RecruitingNot Applicable
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
Canada52 participantsStarted 2025-07-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* \>10 extracranial sites of progressive disease.
* Pregnancy.
* Leptomeningeal disease.
* Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
* Prior radiotherapy near the oligoprogressive lesion precluding SBRT or hypofractionated radiotherapy due to exceeding OAR tolerance.
* Any psychological, sociological or geographical issue potentially hampering compliance with the study.
* Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria