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