Focused radiotherapy to control a few growing melanoma spots

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, prospective, single-arm Phase II trial that treats up to ten extracranial oligoprogressive melanoma lesions with stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy while patients continue first-line systemic therapy. All oligoprogressive sites that can be safely targeted are treated, and patients are followed with imaging to track disease progression. Blood samples are collected at baseline, after radiation, and at progression for exploratory analyses. Outcomes include progression-free survival, overall survival, time on current therapy, toxicity, quality of life, and out-of-field response.

Why it matters

Who can join: the full rules

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's running

• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Jillian C Tsai, MD
• Email: jillian.tsai@uhn.ca
• Phone: 416-946-4501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.