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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
Not Enrolling
Female
Vulvar Cancer

Thank you

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