Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Immunotherapy
- Quality-of-Life Assessment
- Radiation Therapy
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov