Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04594187

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Led by M.D. Anderson Cancer Center · Updated on 2026-02-17

168

Participants Needed

3

Research Sites

331 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 sentinel lymph node biopsy
  • Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension, 0.5 mm or larger nodal tumor implant, two or more 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
Not Eligible

You will not qualify if you...

  • Complete lymph node dissection of the nodal basin containing the positive sentinel lymph node
  • Presence of distant metastasis
  • Previous radiation therapy to the nodal area planned for radiation therapy if it would require re-irradiation of tissues
  • Women who are pregnant
  • Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

Actively Recruiting

2

Cooper Hospital UNIV MED CTR.

Camden, New Jersey, United States, 08103

Actively Recruiting

3

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Devarati Mitra

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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