Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Last updated: June 7, 2013
Sponsor: Gynecologic Oncology Group
Overall Status: Terminated

Phase

3

Condition

Genitourinary Cancer

Vulvar Dysplasia And Carcinoma

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT00006096
CDR0000068103
GOG-0185
  • Female

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both

  • At least 1 positive inguinal and/or femoral lymph node

  • No inoperable (fixed or ulcerating) groin nodes

  • Must not require resection of urethra or anal sphincter to achieve negative margins

  • Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization

  • No metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3

  • Platelet count at least 100,000/mm^3

  • Granulocyte count at least 1,500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal

  • SGOT no greater than 3 times normal

  • Alkaline phosphatase no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant or nursing

  • Fertile patients must use effective contraception

  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

  • No more than 8 weeks since prior surgery

Other:

  • No prior therapy for another malignancy that would preclude study

Study Design

Study Start date:
March 01, 2001
Estimated Completion Date:

Study Description

OBJECTIVES:

  • Compare the recurrence-free interval and survival in patients with stage I, II, III, or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin.

  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms.

  • Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.

  • Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.

Connect with a study center

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Community Hospital of Los Gatos

    Los Gatos, California 95032
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80010
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612-9497
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5289
    United States

    Site Not Available

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • Tufts University School of Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Mallinckrodt Institute of Radiology

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Cancer Center of Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Schneider Children's Hospital at North Shore

    Manhasset, New York 11030
    United States

    Site Not Available

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45267-0502
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ireland Cancer Center

    Cleveland, Ohio 44106-5065
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73190
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Brookview Research, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Simmons Cancer Center - Dallas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • M.D. Anderson CCOP Research Base

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

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