An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Trial Status: active
This phase III 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. Patients with a positive inguinal node will be excluded due to increased risk of radiation-associated toxicity at this site. 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 Criteria
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 or >= 0.5 mm nodal tumor implant, or >= 2 involved nodes, or Primary tumor lymphovascular invasion [LVI])
Enrolled within 11 weeks of sentinel lymph node biopsy
Age 18 years or older
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 Criteria
Complete lymph node dissection (CLND) of the nodal basin containing the positive sentinel lymph node (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
Additional locations may be listed on ClinicalTrials.gov for NCT04594187.
