RecruitingPhase 2NCT04594187

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma

Sponsor

M.D. Anderson Cancer Center

Enrollment

168 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria5

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

Interventions

OTHERImmunotherapy

All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.

OTHERQuality-of-Life Assessment

Ancillary studies

RADIATIONRadiation Therapy

Undergo nodal radiation therapy