Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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: Patient...
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.
Tracking Information
- NCT #
- NCT04594187
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Devarati Mitra M.D. Anderson Cancer Center