BridgeMD
New treatment option for Metastatic Melanoma
Official title Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma
ClinicalTrials.gov ID: NCT07112170
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- \>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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.