Actively Recruiting
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
Eligibility Criteria
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
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
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
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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