Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Sentinel lymph node mapping
Urogenital Diseases+8
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.515 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 72 locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, United StatesOpen Arkansas Cancer Research Center at University of Arkansas for Medical Sciences in Google MapsTodd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, United StatesUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United StatesHelen and Harry Gray Cancer Center at Hartford Hospital
Hartford, United States