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Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment168 people
  • Recruiting US sites3
  • SponsorM.D. Anderson Cancer Center
  • RegistryNCT04594187

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma: a one-minute explainerNCT045941871 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Immunotherapy (Other): 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.
  • Quality-of-Life Assessment (Other): Ancillary studies
  • Radiation Therapy (Radiation): Undergo nodal radiation therapy

The study

Treatment groups

Randomized · Parallel · masking: None

Group I (immunotherapy, radiation therapy) (Experimental)

Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.

Group II (immunotherapy) (Active Comparator)

Patients planned to undergo immunotherapy.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • biopsy: Part of the study plan
  • questionnaires: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Time to regional nodal recurrence (From date of sentinel lymph node biopsy, assessed up to 5 years)

Other goals

  • Time to locoregional recurrence
  • Time to distant metastasis
  • Progression-free survival
  • Overall survival
  • Incidence of long term toxicity
  • Patient reported quality of life

Planned enrollment: 168 (estimated).

Where

Recruiting US sites

  • Baptist - MD Anderson Cancer Center, Jacksonville, Florida
  • Cooper Hospital UNIV MED CTR., Camden, New Jersey
  • M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 9, 2026. Public record; not medical advice.

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