A Phase II Study Assessing Radiation Therapy and Cisplatin Chemotherapy for People with Vulvar Cancer in the Sentinel Lymph Nodes

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Full Title

Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial (NRG-GY024) (CIRB)

Purpose

When vulvar cancer is removed, surgeons examine the first lymph nodes to which cancer might spread (“sentinel lymph nodes”) to see if they contain cancer cells. If the sentinel lymph nodes contain cancer, the usual treatment is more surgery to remove all of the lymph nodes in the groin, followed by several weeks of radiation therapy to reduce the chance that the cancer will come back. However, removing all of the lymph nodes increases the risk of lymphedema, which causes uncomfortable swelling in the legs, as well as an elevated risk of infection.

In this study, researchers are assessing the use of a slightly higher dose of radiation therapy as well as weekly cisplatin chemotherapy for five weeks after vulvar cancer surgery in people with positive sentinel nodes. They want to see if it is effective for reducing cancer recurrence, without subjecting patients to extensive surgery to remove the groin lymph nodes.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have vulvar cancer that has been surgically removed and has spread to the sentinel lymph nodes.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.  

For more information and to ask about eligibility for this study, please contact the office of Dr. Mario Leitao at 212-639-3987.

Protocol

21-439

Phase

II

Disease Status

Newly Diagnosed

Investigator