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
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy
Neil S. Horowitz, MD
Dana-Farber/Brigham and Women's Cancer Center
United States: National Cancer Institutie
|Cleveland Clinic Foundation||Cleveland, Ohio 44195|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|Baystate Medical Center||Springfield, Massachusetts 01199|
|Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Beebe Medical Center||Lewes, Delaware 19958|
|Union Hospital of Cecil County||Elkton MD, Maryland 21921|
|Memorial Medical Center||Springfield, Illinois 62781|
|Phelps County Regional Medical Center||Rolla, Missouri 65401|
|Case Western Reserve University||Cleveland, Ohio 44106|
|Wayne State University||Detroit, Michigan 48202|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|Providence Saint Joseph Medical Center||Burbank, California 91505-4866|
|Hillcrest Hospital Cancer Center||Mayfield Heights, Ohio 44124|
|The Hospital of Central Connecticut||New Britain, Connecticut 06050|
|Saint Joseph's-Candler Health System||Savannah, Georgia 31405|
|University of Hawaii||Honolulu, Hawaii 96813|
|Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield||Springfield, Missouri 65802|
|Saint John's Hospital||Springfield, Missouri 65804|
|Cox Medical Center||Springfield, Missouri 65807|
|Cooper Hospital University Medical Center||Camden, New Jersey 08103|
|Sanford Cancer Center-Oncology Clinic||Sioux Falls, South Dakota 57104|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|Women and Infants Hospital||Providence, Rhode Island 02905|
|Lake University Ireland Cancer Center||Mentor, Ohio 44060|
|Sudarshan K Sharma MD Limted-Gynecologic Oncology||Hinsdale, Illinois 60521|
|Summa Akron City Hospital||Akron, Ohio 44304|
|Sanford USD Medical Center - Sioux Falls||Sioux Falls, South Dakota 57117-5134|
|Christiana Care Health System-Christiana Hospital||Newark, Delaware 19718|
|Cleveland Clinic Cancer Center/Fairview Hospital||Cleveland, Ohio 44111|
|Women's Cancer Care Associates LLC||Albany, New York 12208|