Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

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Brief Title

Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Official Title

Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Brief Summary

      RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.

      PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating
      patients with stage I or stage II cancer of the vulva.
    

Detailed Description

      OBJECTIVES:

        -  Determine the negative predictive value of a negative sentinel lymph node in patients
           with invasive squamous cell carcinoma of the vulva.

        -  Determine the location of the sentinel node in these patients.

      OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of
      the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have
      been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy
      followed by resection of the primary tumor with adequate margins. Preoperative
      lymphoscintigraphy is also performed.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter or until recurrence.

      PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6
      years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Predictive value of negative sentinel lymph nodes in vulvar cancer patients


Condition

Vulvar Cancer

Intervention

Sentinel lymph node mapping

Study Arms / Comparison Groups

 Sentinenal lymph node mapping
Description:  Sentinenal lymph node mapping

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

515

Start Date

December 1999


Primary Completion Date

July 2013

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater
             than 1 mm in thickness as measured from the nearest rete peg

               -  Tumor size must be 2-6 cm

               -  No recurrent disease

          -  Prior excision of the primary disease or a history of carcinoma in situ of the vulva
             allowed

          -  No tumor extending into the urethra, anus, vagina, rectum, or bladder

          -  No grossly suspicious or inflamed groin nodes on physical exam

          -  No grossly infected primary tumors

        PATIENT CHARACTERISTICS:

        Age:

          -  Any age

        Performance status:

          -  GOG 0-3

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  No other invasive malignancy within the past 5 years except non-melanomatous skin
             cancer

          -  No known hypersensitivity to phenylethane compounds

        PRIOR CONCURRENT THERAPY:

          -  No prior cancer therapy that contraindicates therapy in this study

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  See Disease Characteristics

          -  No prior groin dissection
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Charles Levenback, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00003325

Organization ID

GOG-0173

Secondary IDs

CDR0000066277

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Charles Levenback, MD, Study Chair, M.D. Anderson Cancer Center


Verification Date

May 2015