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Protocol NU JW07M1

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
Purpose The overall purpose of the research is to find out if melanoma which is metastatic (has spread) to a sentinel lymph node (first lymph node draining that area of skin) can be treated by removing only the sentinel node from a lymph basin (called a sentinel node biopsy), or if all lymph nodes in a lymph basin must be removed (called a complete lymph node dissection).
Overview This study will compare people who receive sentinel node dissection only with those who also receive a complete lymph node dissection. The study will look at each group for ten years to see if their melanoma spreads. Patients who do not undergo the complete nodal dissection will be followed by ultrasound examinations of the nodal basin in question in addition to standard follow up.
Who May
be Eligible
Some of the eligibility criteria include:
  • Participants must have a primary diagnosis of melanoma.
  • Participants must be undergoing or recently have undergone a sentinel node biopsy.
  • Participants must be 18 years or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Description of Treatment Study participants will be randomized into one of two treatment groups. Randomization means that participants are put into a group by chance. Participants will have an equal chance of being placed in either group. The two treatment groups are: 1. Study participants will receive a complete lymph node dissection. Participants will then see their doctor every four months for two years after randomization, then every six months for the next three years, then once a year for five more years or 2. Participants will be randomized to observation only following the same schedule as noted above as well as a nodal ultrasound at every visit until the end of the fifth year.

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