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

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About this study

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.

Condition
Metastatic Melanoma, OligoProgressive Metastatic Disease
Tested
Stereotactic Body Radiation Therapy (SBRT)
Sponsor
University Health Network, Toronto

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Metastatic Melanoma, OligoProgressive Metastatic Disease
  • 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 7

  • \>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

1 site, 1 recruiting

University Health Network

Toronto, Ontario, Canada

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.