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

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Brief Title

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

Official Title

A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Vulvar Cancer

Intervention

cisplatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

March 2001


Primary Completion Date

January 2003

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
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon), , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00006096

Organization ID

CDR0000068103

Secondary IDs

GOG-0185


Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon), Study Chair, GlaxoSmithKline


Verification Date

June 2007