Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
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.
Drug: isosulfan blue
Procedure: conventional surgery
Procedure: sentinel lymph node biopsy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva|
- Disease status [ Designated as safety issue: No ]
- Tumor characteristics (e.g., stage, clinical tumor size, status of the capillary/lymphatic spaces, and histologic type of tumor) [ Designated as safety issue: No ]
- Host characteristics (e.g., age and performance status) [ Designated as safety issue: No ]
- Adverse effects of the mapping procedure and dissection (i.e., frequency and severity) [ Designated as safety issue: Yes ]
|Study Start Date:||December 1999|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003325
Show 72 Study Locations
|Study Chair:||Charles Levenback, MD||M.D. Anderson Cancer Center|
|Investigator:||Benjamin E. Greer, MD||Fred Hutchinson Cancer Research Center|