GROINSS-V - GOG 270 Study

GROINSS-V - GOG 270 Study

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Groningen international study on sentinal nodes in vulvar cancer (GROINSS-V) II: An observational study

PROTOCOL ID

GOG 270

PROTOCOL DESCRIPTION

In patients with a new diagnosis of vulvar cancer, it is likely that the cancer does not spread to lots of lymph nodes at once, but instead the cancer may spread to just one or two lymph nodes first before moving on to affect others. The first lymph nodes to which the cancer spreads are known as Ôsentinel nodes'.

Previously patients in both the United States and Europe with a diagnosis of vulvar cancer would undergo removal of several lymph nodes in the groin region. More recently, sentinel lymph node removal has been shown to adequately predict lymph node spread. There are fewer side-effects with sentinel node dissection when compared to the older operation in which all lymph nodes were removed.

This is an observational study to investigate whether the current treatment option involving only the removal of sentinel nodes followed by chemotherapy and/or radiation is effective in managing the spread of this type of cancer. Avoiding extensive removal of lymph nodes may reduce the side effects for these women.

ELIGIBILITY CRITERIA

Patients MUST:

  • Patients must be aged 18years or older
  • Patients who have greater than 1mm invasion
  • Patients whose tumors are less than 4cm
  • Tumors must be operable
  • Preoperative imaging does NOT show enlarged or suspicious nodes

Primary Investigator(s)

Janet L. Osborne, M.D.

Contact Information

Vickie Yates, RN
Clinical Research Nurse Coordinator
Phone: 540-204-7635
Email: vlyates@carilionclinic.org