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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

Status
Active
Cancer Type
Gynecologic Cancers
Trial Phase
Phase II
Eligibility
18 and over, Female
Study Type
Treatment
NCD ID
NCT01595061
Protocol IDs
GOG-0279 (primary)
NCI-2012-01964
Study Sponsor
Gynecologic Oncology Group

Summary

RATIONALE: 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.

PURPOSE: 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.

Objectives

OBJECTIVES:

Primary

  • To determine the efficacy of cisplatin, gemcitabine hydrochloride (gemcitabine), 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.

Secondary

  • To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally advanced squamous cell carcinoma of the vulva.
  • To determine the vulvar progression-free survival and groin progression-free survival of women treated with cisplatin, gemcitabine, and IMRT for locally advanced vulvar carcinoma.
  • To determine the toxicity and surgical morbidity of the combined-modality approach of cisplatin, gemcitabine, and IMRT followed by reduced-scope surgery for the treatment of locally advanced vulvar carcinoma.

OUTLINE: This is a multicenter study.

Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

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