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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy
No
Neil S. Horowitz, MD
Principal Investigator
Dana-Farber/Brigham and Women's Cancer Center
United States: National Cancer Institutie
GOG-0279
NCT01595061
August 2012
Name | Location |
---|---|
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 |