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

June 7, 2013 updated by: Gynecologic Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

September 2, 2003

First Posted (Estimate)

September 3, 2003

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068103
  • GOG-0185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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