A Phase III Study of Surgery Followed by Radiation Therapy or Observation in Patients with Neurotropic Melanoma of the Head and Neck

Protocol
13-248
Full Title
A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
Phase
III
Purpose

Neurotropic melanoma is melanoma that develops in or around nerves. It has a high risk of returning in the same area. When this type of melanoma develops in the head and neck area, the standard therapy is surgery. In some hospitals, radiation therapy is given soon after surgery to reduce the risk of cancer recurrence, but this care is not yet standard. It is not yet known if the benefits of immediate radiation therapy after surgery outweigh the risks.

In this study, researchers are comparing surgery followed by radiation therapy with surgery alone in patients with neurotropic melanoma of the head and neck. Patients will be randomly assigned to receive surgery followed by four weeks of radiation therapy to the area where the surgery was performed, or observation without radiation therapy. Patients in the observation group who experience a return of their melanoma can receive radiation therapy at that point.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have neurotropic melanoma of the head and neck which has not spread to lymph nodes or other organs.
  • Patients’ cancers must be able to be removed surgically.
  • Patients may not have had prior radiation therapy to the head and neck area.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Christopher Barker at 212-639-8168.

Disease(s)
Melanoma
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