Multicenter Selective Lymphadenectomy Trial II: A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients with Molecular or Histopathological Evidence of Metastases in the Sentinel Node
The purpose of the study is to determine whether lymph node mapping and sentinel lymph node removal followed by complete lymph node dissection in subjects with tumor positive sentinel lymph nodes leads to longer overall survival than lymph node mapping and sentinel lymph node removal followed by ultrasound observation alone.
*Primary cutaneous melanoma *Age 18-75 *Melanoma related tumor positive sentinel lymph node *Clear tumor margins on biopsy
There are 2 phases in this study: Screening Phase and Treatment Phase. During the screening phase, confirmation of positive sentinel lymph node is performed by pathology confirmation. Subjects confirmed positive are them entered into the randomization phase which consists of 2 arms: *Subject randomized to complete lymph node dissection (must be done within 120 days of original biopsy). *Subject randomized to observation with serial node ultrasound performed every 4 months for 2 years, then every 6 months for 3 years. Subjects remain in follow up for up to 10 years. Subjects found to be sentinel node negative after the screening phase will not be randomized but will be followed for recurrence of melanoma.
06/03/2015 09:19 AM