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
Brief description of study.
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Vulvar Cancer
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Age: 18 years - 100 years
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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
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.
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