Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.

Completed · Not applicable

Conditions studied: Vulvar Cancer

In brief

The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women \& Infants Hospital

Key facts

Study ID

NCT00315159

Run by

Women and Infants Hospital of Rhode Island

People needed

74

Starts

2003-08-01

Expected to finish

2014-05-01

Last updated by the study team

2015-01-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient of any age 18 years or over.
• Biopsy proven squamous cell carcinoma of the vulva.
• Depth of invasion 1mm or greater.
• Patients with groins clinically negative for nodal metastasis.
• Patients that are candidates for groin dissections.

You may not qualify if…

• Any patient below the age of 18
• Patients with clinically suspicious groin nodes for metastatic disease.
• Patients with non-squamous cell vulvar lesions.
• Depth of invasion less than 1mm.
• Patients refusing to sign an informed consent form.

Where it is running

• Women and Infants' Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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