TrialBridgeNCT04594187
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Recruiting · Phase 2 · M.D. Anderson Cancer Center · registry updated 2026-08-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
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
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