At a glance
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A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
In Brief
A Phase 2 clinical trial evaluating Cisplatin, Gemcitabine Hydrochloride, and 2 other interventions for Stage III Vulvar Cancer AJCC v7 and 5 related conditions. Targeting 57 participants across 193 sites.
Detailed Summary
This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Study Details
Timeline
Interventions
Given IV
Given IV
Undergo IMRT
Undergo local core biopsy or surgical excision