A Phase 3 interventional study of Sentinel lymph node mapping in Vulvar Cancer, sponsored by Gynecologic Oncology Group. Completed at 72 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2015-05-29.
Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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.
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.
210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.
This study's enrollment of 515 is above the median of 55 across 151 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Sentinenal lymph node mapping
Procedure: Sentinel lymph node mapping
Sentinel lymph node mapping
Predictive value of negative sentinel lymph nodes in vulvar cancer patients
Time frame: at time of surgery
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group