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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 Advances Squamous Cell Carcinoma of the Vulva

Investigating Radiation Therapy with Investigational Medications for squamous cell carcinoma of the Vulva

Enrolling By Invitation
18 years and older
Female
Phase N/A

This study investigates the effectiveness of using radiation therapy along with investigational medications in treating patients with a type of skin cancer called squamous cell carcinoma of the vulva. Squamous cell carcinoma is a cancer that begins in the flat cells lining the vulva, which is the outer part of the female genitals. This study focuses on cases where the cancer is locally advanced, meaning it has spread to nearby tissues but not to distant body parts.

Participants in the study will receive radiation therapy combined with investigational medications. Radiation therapy uses high-energy rays to kill cancer cells, while the investigational medications are substances being tested to see if they can improve treatment outcomes. One of the medications used in this study is a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

  • Who can participate: Adults with locally advanced, previously untreated squamous cell carcinoma of the vulva may participate. Eligible candidates have T2 or T3 primary tumors that cannot be surgically removed by standard radical vulvectomy and must meet certain health criteria, including specific blood cell counts.
  • Study details: Participants will undergo radiation therapy and receive investigational medications. Some participants will receive a placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine.
Study details
    Squamous Cell Carcinoma of the Vulva
    Squamous Cell Carcinoma
    Squamous Cell
    Carcinoma
    Cancer
    Vulva Cancer
    Oncology

TX3229

15 July 2026

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