A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
Phase 2
N/A
N/A
N/A
N/A
Not Enrolling
Female
Vulvar Cancer
Female
Vulvar Cancer
Trial Information
A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
OBJECTIVES:
- Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete
clinical and pathological response, in patients with locally advanced squamous cell
carcinoma of the vulva that is not amenable to standard radical vulvectomy.
- Determine the toxicity of this regimen followed by surgery in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30
minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32
fractions of radiotherapy) in the absence of unacceptable toxicity.
Six to eight weeks after the completion of chemoradiotherapy, patients with a complete
clinical response may undergo incisional biopsy of the primary tumor and bilateral
inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with
microscopic or gross resectable residual disease may then undergo radical resection of the
residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy
receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 1.8-2.3
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of locally advanced squamous cell carcinoma of the vulva
- T3 or T4 (N0-3, M0)
- Not amenable to surgical resection by standard radical vulvectomy
- Previously untreated disease
- No recurrent disease
- No vulvar melanoma or sarcoma
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- GOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times normal
- Alkaline phosphatase no greater than 3 times normal
- SGOT no greater than 3 times normal
Renal
- Creatinine no greater than 2.0 mg/dL
Gastrointestinal
- No gastrointestinal bleeding
- No severe gastrointestinal symptoms
Other
- Capable of tolerating a radical course of chemoradiotherapy
- No septicemia
- No severe infection
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No circumstance that would preclude study completion or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic radiotherapy
- No concurrent boost brachytherapy
Surgery
- Not specified
Other
- No prior anticancer therapy that would contraindicate study therapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete clinical and pathologic tumor response at completion of treatment
Safety Issue:
No
Principal Investigator
David H. Moore, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gynecologic Oncology of Indiana
Authority:
United States: Federal Government
Study ID:
CDR0000322259
NCT ID:
NCT00068406
Start Date:
January 2005
Completion Date:
Related Keywords:
- Vulvar Cancer
- squamous cell carcinoma of the vulva
- stage III vulvar cancer
- stage IVB vulvar cancer
- Carcinoma, Squamous Cell
- Vulvar Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
| Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
| Yale Cancer Center | New Haven, Connecticut 06520-8028 |
| Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| American Fork Hospital | American Fork, Utah 84003 |
| Logan Regional Hospital | Logan, Utah 84321 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| South Bend Clinic | South Bend, Indiana 46617 |
| Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Parkland Memorial Hospital | Dallas, Texas 75235 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| Menorah Medical Center | Overland Park, Kansas 66209 |
| Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
| Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
| St. Joseph Medical Center | Kansas City, Missouri 64114 |
| North Kansas City Hospital | Kansas City, Missouri 64116 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Research Medical Center | Kansas City, Missouri 64132 |
| Liberty Hospital | Liberty, Missouri 64068 |
| Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| St. John's Regional Medical Center | Joplin, Missouri 64804 |
| Independence Regional Health Center | Independence, Missouri 64050 |
| Parvin Radiation Oncology | Kansas City, Missouri 64116 |
| Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
| Gynecologic Oncology of West Michigan | Grand Rapids, Michigan 49546 |
| Hall and Martin, M.Ds., PC | Knoxville, Tennessee 37920 |
