Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Start Date
8/26/2021
Completion Date
12/31/2027
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.
Detailed Description
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
Age Range: 18 years to No maximum
Interventions
Immunotherapy
Quality-of-Life Assessment
Radiation Therapy
Conditions
Locations
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