Title Multicenter Selective Lymphadenectomy for Melanoma 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
Principal Investigator John Kane III, MD
Study Number 47505
Summary MSLT-II ia a phase III multicenter, prospective, randomized clinical trial to determine if LM/SL and CLND for tumor-positive SN improves melanoma-specific survival compared to LM/SL alone followed by observation with serial nodal ultrasound in subjects with histopathologic or molecular evidence of metastases in the SN.
- Between 18 and 75 years of age
- Have a primary melanoma that is cutaneous
- ECOG performance of 0-1
- Have a melanoma-related tumor-positive SN, determined by either of the following methods a). Diagnosis of tumor-positive SN by MSLT-II center institutional pathologist by either H&N or IHC (using S-100, Mart-1, and HMB-45). b). Diagnosis of tumor-positive SN by RT-PCR analysis performed a JWCI, provided the primary melanoma fits into one of the following categories:
1. Breslow thickness of 1.20mm of greater and Clark Level III
2. Clark Level IV or V, regardless of Breslow thickness
3. Ulceration, regardless of Breslow thickness or Clark level.