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

NCT00315159 | Completed DMC

• 1 other identifier: 03-0031
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vulvar Cancer

Keywords

Squamous; Cell; Carcinoma; Vulva; Sentinel Node

Outcome Measures

Primary Outcomes (1)

• Determination of inguinal recurrence rates in patients with negative sentinel lymph node biopsy alone.

  Three years

Secondary Outcomes (1)

• Ability to detect inguinal sentinel nodes in vulvar cancer patients.

  Three years

Study Arms (1)

No intervention

NO INTERVENTION

Patients with negative SLN will be followed on no intervention arm

Procedure: Sentinel Node Biopsy

Interventions

Sentinel Node Biopsy PROCEDURE

Inguinal sentinel node biopsy will be performed.

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants' Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Vulvar Neoplasms; Carcinoma

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Richard G Moore, MD

  Women and Infants' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Richard Moore, M.D.

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: August 1, 2003
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

US (1)