Protocol
09-112
Full Title
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 purpose of this study is to find out if melanoma can be treated by removing only a few “sentinel” lymph nodes from a lymph basin (a procedure called a “sentinel node dissection”), or if all lymph nodes in the lymph basin must be removed (an approach called “complete lymph node dissection”). The lymph node basin includes all the nodes in an area where a sentinel lymph node biopsy is performed (such as the armpit or groin).
Researchers will compare patients who receive sentinel node dissection only and are followed with ultrasound with patients who receive a complete lymph node dissection. They will monitor each group for ten years to see if the melanoma spreads and to study survival and other patient factors.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have cutaneous melanoma that has spread to a sentinel node.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be between the ages of 18 and 75.
For more information and to inquire about eligibility for this study, please contact Dr. Charlotte Ariyan at 212-639-6280.
Disease(s)
Melanoma
Locations
ClinicalTrials.gov
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