Recruiting

SBRT

Sponsor:

University Health Network, Toronto

Code:

NCT07112170

Conditions

Metastatic Melanoma

OligoProgressive Metastatic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief 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.

Conditions

Metastatic Melanoma

OligoProgressive Metastatic Disease

Study ID

NCT07112170

Start date

Jul 24, 2025

Status verified date

Mar, 2026

Completion date

Jul 24, 2028

Anticipated

Primary completion date

Jul 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered as per institutional standard.

Primary outcome measure

  • Progression-Free Survival (PFS) assessed by radiological imaging using RECIST v1.1 criteria [ Time Frame: From enrollment up to 24 months ]

Central Contacts and Locations

Central contacts

Jillian C Tsai, MD

416-946-4501jillian.tsai@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Jillian C Tsai, MD

416-946-4501jillian.tsai@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • stereotactic body radiation therapy (SBRT)
  • Melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.