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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003325 |
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.
Condition | Intervention | Phase |
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Vulvar Cancer |
Drug: isosulfan blue Procedure: conventional surgery Procedure: sentinel lymph node biopsy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva |
Estimated Enrollment: | 630 |
Study Start Date: | December 1999 |
Estimated Primary Completion Date: | November 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Charles Levenback, MD | M.D. Anderson Cancer Center |
Investigator: | Benjamin E. Greer, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000066277, GOG-173 |
Study First Received: | November 1, 1999 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00003325 History of Changes |
Health Authority: | United States: Federal Government |
stage I vulvar cancer stage II vulvar cancer squamous cell carcinoma of the vulva |
Genital Diseases, Female Vulvar Neoplasms Vulvar Cancer Epidermoid Carcinoma Genital Neoplasms, Female |
Urogenital Neoplasms Squamous Cell Carcinoma Carcinoma, Squamous Cell Vulvar Diseases Carcinoma |
Genital Diseases, Female Neoplasms Neoplasms by Site Vulvar Neoplasms |
Genital Neoplasms, Female Urogenital Neoplasms Vulvar Diseases |