Tests radiation to lymph nodes for melanoma that has spread to sentinel lymph nodes
Tests radiation to nearby lymph nodes in adults with high-risk melanoma spread to sentinel nodes.
Key facts
- Who runs it
- M.D. Anderson Cancer Center
- Where
- Camden, Houston, and Jacksonville, United StatesSee the 3 sites
- Trial code
- Registry title
- Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 168 people, planned
- Started
- 7 Aug 2020
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Immunotherapy
- Quality-of-Life Assessment
- Radiation Therapy
- Record updated
- 10 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with melanoma that has reached a sentinel lymph node and has high-risk features, who are planned for immunotherapy after surgery.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Melanoma with a positive sentinel lymph node and high-risk features: spread outside the node capsule, a 0.5 mm+ tumor deposit in the node, 2+ involved nodes, or invasion of lymph vessels by the primary tumor. No distant spread and no clinically involved lymph nodes before the sentinel node biopsy.
- Earlier treatment
- Must be planned for immunotherapy after surgery. Must not have had a complete lymph node dissection of the area with the positive node. Must not have had earlier radiation to the area that would need to be treated again.
Main reasons for not taking part
- Complete lymph node dissection of the area with the positive sentinel node
- Distant metastasis
- Earlier radiation to the same area, so tissue would be irradiated again
- Pregnancy
- Unable to consent, or ECOG performance status above 3
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Where in United States
- Cooper Hospital UNIV MED CTR.Camden, United StatesContact: Gregory Kubicek, MDTaking people
- M D Anderson Cancer CenterHouston, United StatesContact: Devarati MitraTaking people
- Baptist MD Anderson Cancer CenterJacksonville, United StatesContact: Cynthia Anderson, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group I (immunotherapy, radiation therapy)Treatment being tested
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.
Treatment: Immunotherapy, Quality-of-Life Assessment, and Radiation Therapy
- Group II (immunotherapy)Existing treatment, for comparison
Patients planned to undergo immunotherapy.
Treatment: Immunotherapy and Quality-of-Life Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
- Plain-language title
- Tests radiation to lymph nodes for melanoma that has spread to sentinel lymph nodesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 August 2026