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
This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva. 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 or by stopping them from dividing. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
The purpose of this study is to determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and Intensity-Modulated Radiation Therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.
- IRB Number: GOG279
- Research Study Identifier: TX4063
- Principal Investigator: Frederick Stehman, MD