Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
ECOG 0-2
Willing and able to provide informed consent
Metastatic melanoma detected on imaging and clinically confirmed.
Disqualifiers
>10 extracranial sites of progressive disease.
Pregnancy.
Leptomeningeal disease.
Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Body Radiation Therapy (SBRT)
RadiationSBRT will be delivered as per institutional standard.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria
To determine if the addition of SBRT or hypofractionated radiation to progressive lesions improves progression-free survival in patients with metastatic melanoma. Radiological progression will be evaluated using CT, PET-CT, or MRI according to RECIST v1.1.
Time frame
From enrollment up to 24 monthsSecondary outcomes
1
Overall Survival (OS) measured from date of enrollment to death from any cause
Time frame
Enrollment up to 24 months2
Time on Current Systemic Therapy After Initial Oligoprogression
Time frame
From enrollment up to 24 months3
Out-of-field response assessed by radiological imaging (CT, PET-CT, or MRI)
Time frame
From enrollment up to 24 months.4
Reporting acute and late toxicities of SBRT
Time frame
Enrollment up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov