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Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
NCT04594187 · M.D. Anderson Cancer Center
In plain English
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Official title
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
About this study
PRIMARY OBJECTIVE:
I. To determine if regional nodal radiation therapy prolongs the time to regional recurrence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks).
GROUP II: Patients receive adjuvant immunotherapy alone.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 168 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-08-26
Estimated completion: 2027-12-31
Last updated: 2026-02-17
Interventions
Other: ImmunotherapyOther: Quality-of-Life AssessmentRadiation: Radiation Therapy
Primary outcomes
- • Time to regional nodal recurrence (From date of sentinel lymph node biopsy, assessed up to 5 years)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactDevarati Mitra · contact · dmitra@mdanderson.org · 713-563-1339
InvestigatorDevarati Mitra · principal_investigator, M.D. Anderson Cancer Center
All locations (3)
Baptist - MD Anderson Cancer CenterRecruiting
Jacksonville, Florida, United States
Cooper Hospital UNIV MED CTR.Recruiting
Camden, New Jersey, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States