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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006096
Recruitment Status : Terminated
First Posted : September 3, 2003
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Vulvar Cancer Drug: cisplatin Radiation: radiation therapy Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
Study Start Date : March 2001
Actual Primary Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer
Drug Information available for: Cisplatin

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy


  • See Disease Characteristics
  • No more than 8 weeks since prior surgery


  • No prior therapy for another malignancy that would preclude study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006096

  Show 30 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) GlaxoSmithKline Identifier: NCT00006096     History of Changes
Other Study ID Numbers: CDR0000068103
First Posted: September 3, 2003    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2007

Keywords provided by Gynecologic Oncology Group:
stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer
stage IVB vulvar cancer
squamous cell carcinoma of the vulva

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female
Antineoplastic Agents