Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
Recruiting · NCT07112170 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- University Health Network - Toronto, Ontario, Canada