Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
MelPORT
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
2 other identifiers
interventional
168
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2021
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 17, 2026
February 1, 2025
6.4 years
October 10, 2020
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to regional nodal recurrence
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up
From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary Outcomes (6)
Time to locoregional recurrence
From date of sentinel lymph node biopsy, assessed up to 5 years
Time to distant metastasis
From date of sentinel lymph node biopsy, assessed up to 5 years
Progression-free survival
From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Overall survival
From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Incidence of long term toxicity
Up to 5 years
- +1 more secondary outcomes
Other Outcomes (2)
Tissue associated biomarkers of disease control and radiation-associated toxicity
Up to 5 years
Optional blood associated biomarkers of disease control and radiation-associated toxicity
Up to 5 years
Study Arms (2)
Group I (immunotherapy, radiation therapy)
EXPERIMENTALWithin 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.
Group II (immunotherapy)
ACTIVE COMPARATORPatients planned to undergo immunotherapy.
Interventions
All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
Ancillary studies
Undergo nodal radiation therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devarati Mitra
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2020
First Posted
October 20, 2020
Study Start
August 26, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 17, 2026
Record last verified: 2025-02