NCT04594187RecruitingPhase 2
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 10 Oct 2020
- Start date
- 7 Aug 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT04594187
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 168
- From 7 Aug 2020 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
- Distant metastasis
- Women who are pregnant
- Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cooper Hospital UNIV MED CTR. Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.