Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma

NCT07112170 | Recruiting DMC

• 1 other identifier: 25-5162
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

OligoProgressive Metastatic Disease; Metastatic Melanoma

Keywords

stereotactic body radiation therapy (SBRT); Melanoma

Outcome Measures

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.

  From enrollment up to 24 months

Secondary Outcomes (6)

• Overall Survival (OS) measured from date of enrollment to death from any cause

  Enrollment up to 24 months

• Time on Current Systemic Therapy After Initial Oligoprogression

  From enrollment up to 24 months

• Out-of-field response assessed by radiological imaging (CT, PET-CT, or MRI)

  From enrollment up to 24 months.

• Reporting acute and late toxicities of SBRT

  Enrollment up to 24 months

• Participant-reported adverse events measured using PRO-CTCAE questionnaire

  From baseline through follow-up (up to 24 months)

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

SBRT will be delivered as per institutional standard.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \>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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jillian C Tsai, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 8, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 24, 2027
• Study Completion (Estimated): July 24, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)