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TerminatedNCT00006096Updated Jun 10, 2013

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

A Phase 3 interventional study of cisplatin and radiation therapy in Vulvar Cancer, sponsored by Gynecologic Oncology Group. Terminated at 30 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2013-06-10.

Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Sex
Female
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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.

Read the detailed 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.

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Conditions studied

  • Vulvar Cancer

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Keywords

  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IVB vulvar cancer
  • squamous cell carcinoma of the vulva
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In context

Vulvar Neoplasms

210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.

Browse Vulvar Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Drugcisplatin
  • Radiationradiation therapy
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Study locations

30 sites
  • Community Hospital of Los Gatos
    Los Gatos, California 95032, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of Colorado Cancer Center
    Denver, Colorado 80010, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Holden Comprehensive Cancer Center at The University of Iowa
    Iowa City, Iowa 52242-1009, United States
  • Tufts University School of Medicine
    Boston, Massachusetts 02111, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri 65203, United States
  • Mallinckrodt Institute of Radiology
    Saint Louis, Missouri 63108, United States
  • Cancer Center of Albany Medical Center
    Albany, New York 12208, United States
  • Schneider Children's Hospital at North Shore
    Manhasset, New York 11030, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Comprehensive Cancer Center at Wake Forest University
    Winston-Salem, North Carolina 27157-1082, United States
  • Barrett Cancer Center, The University Hospital
    Cincinnati, Ohio 45267-0502, United States
  • Ireland Cancer Center
    Cleveland, Ohio 44106-5065, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio 43210-1240, United States
  • University of Oklahoma College of Medicine
    Oklahoma City, Oklahoma 73190, United States
  • Abington Memorial Hospital
    Abington, Pennsylvania 19001, United States
  • Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
  • Brookview Research, Inc.
    Nashville, Tennessee 37203, United States
  • Simmons Cancer Center - Dallas
    Dallas, Texas 75235-9154, United States
  • M.D. Anderson CCOP Research Base
    Houston, Texas 77030-4009, United States
  • Fletcher Allen Health Care - Medical Center Campus
    Burlington, Vermont 05401, United States
  • Tacoma General Hospital
    Tacoma, Washington 98405, United States
  • Tom Baker Cancer Center - Calgary
    Calgary, Alberta T2N 4N2, Canada
  • Toronto Sunnybrook Regional Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006096
Lead sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
Sep 3, 2003
Start date
Mar 2001
Primary completion
Jan 2003
Last update
Jun 10, 2013

Study contacts

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
study chair · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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