Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva
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.
Drug: gemcitabine hydrochloride
Procedure: therapeutic conventional surgery
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy [ Designated as safety issue: No ]
- Complete clinical response [ Designated as safety issue: No ]
- Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0 [ Designated as safety issue: Yes ]
- Progression-free survival (PFS) estimated according to the method of Kaplan and Meier [ Designated as safety issue: No ]
- Overall survival (OS) estimated according to the method of Kaplan and Meier [ Designated as safety issue: No ]
- Site(s) of disease recurrence/relapse classified as local (vagina or vulva), loco-regional (within the pelvic), or distant tabulated by response status [ Designated as safety issue: No ]
- Treatment compliance [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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.