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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006096
First received: August 3, 2000
Last updated: June 7, 2013
Last verified: June 2007
History of Changes
  Purpose

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 Intervention Phase
Vulvar Cancer
 Drug: cisplatin
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Study Start Date: March 2001
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006096

  Show 30 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) GlaxoSmithKline
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00006096     History of Changes
Other Study ID Numbers: CDR0000068103, GOG-0185
Study First Received: August 3, 2000
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Vulvar Diseases
Genital Diseases, Female
 Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013