Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,001
Subject has wide excision and sentinel lymph node dissection for primary melanoma.
Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.
Subject has wide excision only for primary melanoma.
To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone.
Time frame: 10 years
Disease-free survival; Incidence, timing, and anatomic distribution of distant metastases; Morbidity of procedures; Significance of TA90 levels; Incidence of Sentinel Node Metastases (biopsy) vs clinical metastases (observation); Accuracy of LM
Time frame: 10 years
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