Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- Immunotherapy (other)
- Quality-of-Life Assessment (other)
- Radiation Therapy (radiation)
Sponsor: M.D. Anderson Cancer Center · Participants: 168 · Started: Aug 7, 2020
Contact the study team
- Devarati Mitra · Phone: 713-563-1339
Official record on ClinicalTrials.gov — NCT04594187
Locations in the U.S.
| Florida | Baptist - MD Anderson Cancer Center, Jacksonville |
| New Jersey | Cooper Hospital UNIV MED CTR., Camden |
| Texas | M D Anderson Cancer Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.