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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vulvar Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
Inclusion Criteria
Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
Patients judged capable of tolerating a radical course of chemoradiation therapy
Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients with a GOG performance status of 0, 1, or 2
Exclusion Criteria
Patients with recurrent carcinoma of the vulva regardless of previous treatment
Patients who have received prior pelvic radiation or cytotoxic chemotherapy
Patients with vulvar melanomas or sarcomas
Patients with circumstances that will not permit completion of the study or the required follow-up
Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy


Currently Recruiting

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