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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

Radiation and Chemotherapy for Vulvar Cancer

Recruiting
18 years and older
Female
Phase N/A

This study investigates the use of radiation therapy combined with chemotherapy drugs, gemcitabine hydrochloride and cisplatin, in treating patients with locally advanced squamous cell carcinoma of the vulva. Squamous cell carcinoma is a type of skin cancer that can develop in various parts of the body, including the vulva. The purpose of this study is to see how well these treatments work together to kill cancer cells and reduce tumor size.

Participants will undergo a procedure called Intensity-Modulated Radiation Therapy (IMRT), which delivers targeted radiation to the tumor. This is combined with chemotherapy, where gemcitabine hydrochloride and cisplatin are used to stop the growth of cancer cells. These drugs can kill the cells or stop them from dividing, which may help in achieving a complete response to the treatment.

  • Who can participate: Patients with locally advanced, untreated squamous cell carcinoma of the vulva with T2 or T3 primary tumors that cannot be surgically removed can participate. They must tolerate chemoradiation therapy and not qualify for higher priority protocols.
  • Study details: Participants will receive radiation therapy and chemotherapy. Chemotherapy involves gemcitabine hydrochloride and cisplatin to stop cancer cell growth, while radiation therapy uses IMRT to target the tumor. A placebo is not used in this study.
Study details
    Vulvar Cancer

TX4063

19 February 2024

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