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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 CenterSeattle, Washington  98109
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
LDS HospitalSalt Lake City, Utah  84143
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Elkhart General HospitalElkhart, Indiana  46515
Gynecologic Oncology of IndianaIndianapolis, Indiana  46237
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Parkland Memorial HospitalDallas, Texas  75235
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Evanston HospitalEvanston, Illinois  60201-1781
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
St. John's Regional Medical CenterJoplin, Missouri  64804
Independence Regional Health CenterIndependence, Missouri  64050
Parvin Radiation OncologyKansas City, Missouri  64116
Central Georgia Gynecologic OncologyMacon, Georgia  31201
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Hall and Martin, M.Ds., PCKnoxville, Tennessee  37920