NCT04594187
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~168 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:ImmunotherapyQuality-of-Life AssessmentRadiation Therapy
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to regional nodal recurrence
Measured over From date of sentinel lymph node biopsy, assessed up to 5 years
Conditions
Where it's being run
3 sites across 3 statesFlorida1
New Jersey1
Texas1
Study leadership
- Devarati Mitra · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Must be planned for post-operative immunotherapy
No evidence of distant metastasis as determined by clinical examination and any form of imaging
No evidence of clinically involved lymph nodes prior to SLNB
Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \[ECE\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
Has provided written informed consent for participation in this trial
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
Life expectancy greater than 6 months
Patients capable of childbearing are using adequate contraception
Available for follow-up
Exclusion
Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
Distant metastasis
Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues
Women who are pregnant
Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
What this trial measures
- Time to regional nodal recurrenceFrom date of sentinel lymph node biopsy, assessed up to 5 years
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up